Request History

• Restore to current request
• applications/index/page:69/sort:study_title/direction:desc/approved:1
• applications/index/page:73/sort:protocol_no/direction:desc/approved:2
• applications/index/page:76/sort:study_title/direction:asc/approved:2
• applications/index/page:68/sort:protocol_no/direction:asc/approved:1

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1746075550
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • page73
  • sortstudy_title
  • directiondesc
  • approved2
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page73
    • current5
    • count502
    • prevPage(true)
    • nextPage(true)
    • pageCount101
    • order(array)
      • Application.study_titledesc
    • limit5
    • options(array)
      • page73
      • order(array)
        • Application.study_titledesc
      • sortstudy_title
      • directiondesc
    • paramTypenamed

Post data

• Application(array)
  • approved2

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

• keys(array)
  • 0controller
  • 1action
• options(empty)
• defaults(array)
  • plugin(null)
• template/:controller/:action/*

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id376
      • user_id255
      • trial_status_id6
      • abstract_of_study<p>\n <strong><u> SYNOPSIS</u></strong><br />\n Study title<br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n Trial Design Immediate vs delayed study<br />\n <u>Study Population</u><br />\n HIV-1/2 negative, females at low risk of HIV aged 18-50 years of<br />\n age.<br />\n Planned Sample Size 44<br />\n Planned Trial Period 13 months after recruitment<br />\n Primary Outcome To measure cervical mucosal immune activation after VZVvaccination<br />\n in the context of VZV-effector responses.<br />\n <u>Secondary Objective</u><br />\n To measure the effector VZV-specific CD8+ T cells at the rectal<br />\n mucosa after VZV vaccination;<br />\n To compare the immune activation observed in mucosal tissues<br />\n and in blood.<br />\n <u>Primary Endpoint</u><br />\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.<br />\n <u>Secondary endpoints</u><br />\n An increase in the percentage of VZV-specific CD8+T cells at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. This increase must be significantly different<br />\n from the change observed in the same period for the delayed group<br />\n in order to be considered associated to vaccination.<br />\n To compare the expression of co-receptors and activation markers<br />\n such as CCR5, α4β7, CD38, CD69 and HLA-DR in blood and<br />\n cervical CD4+T cells at 3 months after immunization with<br />\n varicella vaccine.<br />\n Investigational<br />\n Medicinal Product<br />\n Zostavax®<br />\n KAVI-VZV-001 Version 2.0 (01 September 2014) Page 9 of 49<br />\n Dose Zostavax® >19,400 PFU (Z)<br />\n Route Subcutaneous needle injection<br />\n <u>Study Design</u><br />\n Vaccination Period<br />\n Group No. Wk 0 Wk 12<br />\n Immediate 22 Z -<br />\n Delayed 22 - Z<br />\n <u>Follow-Up Duration</u><br />\n After the vaccination with Zostavax®, the delayed groups will be<br />\n followed-up for 9 months and the immediate groups for 12<br />\n months.<br />\n Trial Sponsor University of Toronto, Canada</p>\n
      • study_title<p style=\"text-align: justify;\">\n <br />\n <u><strong>Study title</strong></u><br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n  </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/01/02
      • version_noVersion No: 2.0 (01 September 2014)
      • date_of_protocol01-09-2014
      • study_drugVaricella Zoster Virus vaccine Zostavax® (Merck)
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameZostavax®
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressEmutisya@kaviuon.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKAVI-Institute of Clinical Research (KAVI-ICR) University of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya
      • declaration_date115-01-2015
      • declaration_principal_investigatorProfessor Walter Jaoko, MB, ChB, MTropMed, PhD, Site Principal Investigator
      • declaration_date215-01-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. Healthy females, as assessed by a medical history, physical examination and<br />\n laboratory tests, with no chronic medical condition;<br />\n 2. Aged at least 18 years on the day of screening and no greater than 50 years on the day<br />\n of the first vaccination.<br />\n 3. VZV-seropositive, as assessed by the VIDAS assay.4. Ability to comply with the study requirements and available for follow-up for the<br />\n planned duration of the study.<br />\n 5. In the opinion of the Principal Investigator or designee, the volunteer has understood<br />\n the information provided and signed the consent document.<br />\n 6. Willing to undergo HIV testing, HIV counselling and receive HIV test results.<br />\n 7. For women with potential to become pregnant, willing to use effective contraception<br />\n or barrier methods to avoid pregnancy during the study (spermicides or chemicals are<br />\n not allowed).<br />\n  </p>\n
      • principal_exclusion_criteria<p>\n Any relevant abnormality on history or examination including history of tuberculosis,<br />\n immunodeficiency or autoimmune disease, or use of systemic corticosteroids,<br />\n immunosuppressive, antiviral, anticancer or other medication that, in the opinion of the<br />\n Principal Investigator or designee, is clinically significant. (Note: use of inhaled steroids for<br />\n asthma or use of topical steroids for localized skin conditions will not exclude a volunteer<br />\n from participation) and/or:<br />\n 1. A high risk for HIV-acquisition defined by the experience of any of the follow<br />\n situations:<br />\n a) Had unprotected vaginal or anal sex with a known HIV-1-infected person, a<br />\n person known to be at high risk for HIV or a casual partner (i.e., no continuing,<br />\n established relationship) within the previous 6 months;<br />\n b) Engaged in sex work for money or drugs within the previous 6 months;<br />\n c) Used injection drugs;<br />\n d) Abuse of illicit or prescribed drugs, including alcohol;<br />\n e) Acquired one of the following sexually transmitted infection: chlamydia,<br />\n gonorrhoea and syphilis in the last 12 months;<br />\n f) More than 1 sexual partner within the last 6 months;<br />\n g) New sexual partner within the last 3 months.<br />\n 2. Persistent or recurrent bacterial vaginosis or vaginal candidiasis unresponsive to<br />\n therapy (2 consecutive attempts by study team).<br />\n 3. Confirmed HIV-1 or HIV-2 infection.<br />\n 4. Any clinically significant acute or chronic medical condition that is considered<br />\n progressive or, in the opinion of the Principal Investigator or designee, would make<br />\n the volunteer unsuitable for the study (active or underlying diabetes, gastrointestinal,<br />\n cardiovascular, malignancy, neurological, psychiatric, metabolic, renal, hepatic,<br />\n respiratory, auto-immune diseases, psoriasis, primary and acquired immunodeficiency<br />\n KAVI-VZV-</p>\n<p>\n status and rectal problems).<br />\n 5. Any of the following abnormal laboratory parameters except that one abnormal<br />\n laboratory test may be repeated once if thought to be due to a temporary condition:<br />\n Haematology<br />\n a) Haemoglobin < 9.0 g/dl<br />\n b) Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /l, ≥ 550 /l)<br />\n Coagulation<br />\n - INR <1.0 or >1.5<br />\n 6. Evidence of coagulopathy demonstrated by a reduced level of platelets or a history of<br />\n 3 or more episodes of uncontrolled bleeding from their mouth, nose or other mucous<br />\n membrane (marked by excessive bleeding of more than 30 min).<br />\n 7. A positive pregnancy test or breast-feeding at screening; for the participants with<br />\n reproductive potential, unwilling to use an effective method of preventing pregnancy<br />\n during the study.<br />\n 8. Receipt of vaccine within the previous 2 months or planned receipt at any time until 6<br />\n months after vaccination with Zostavax®.<br />\n 9. Receipt of blood transfusion or blood products within the previous 6 months.<br />\n 10. Participation in another clinical trial currently or within the previous 3 months.<br />\n 11. History of severe or very severe local or systemic reactogenicity events after<br />\n vaccination, or history of severe or very severe allergic reactions.<br />\n 12. History of toxic shock syndrome.<br />\n 13. Confirmed diagnosis of acute or chronic hepatitis B virus infection (spontaneous<br />\n clearance leading to natural immunity, indicated by antibodies to core + antigens, is<br />\n not an exclusion criterion); confirmed diagnosis of hepatitis C virus infection.<br />\n 14. Immunosuppressive medications 30 days before or during the study period.<br />\n 15. History of anaphylactic/anaphylactoid reaction to neomycin (each dose of<br />\n reconstituted vaccine contains trace quantities of neomycin).<br />\n 16. Major psychiatric illness including any history of schizophrenia or severe psychosis,<br />\n bipolar disorder, suicidal attempt or ideation in the previous 3 years.<br />\n 17. Contra-indication for undergoing a biopsy due to bleeding diathesis, haemorrhoids,<br />\n mucosal infection at the biopsy site, medication that interfere with clotting (e.g.<br />\n warfarin or heparin) – both clinical and laboratory.<br />\n 18. Any other reason as determined by the Principal Investigator</p>\n
      • primary_end_points<p>\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifycharacterization of mucosal immune response.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n Name</p>\n </td>\n <td>\n <p>\n Designation</p>\n </td>\n <td>\n <p>\n Qualifications</p>\n </td>\n <td>\n <p>\n Years in research</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Omu Anzala</p>\n </td>\n <td>\n <p>\n Co-Investigator</p>\n </td>\n <td>\n <p>\n MBChB, diploma epidemiology, PhD medical microbiology and infectious disease, post doc fellow molecular immunology group institute of molecular medicine oxford university</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Walter Jaoko</p>\n </td>\n <td>\n <p>\n Principal Investigator</p>\n </td>\n <td>\n <p>\n MBChB, MSc tropical medicine, diploma research methodology, PhD medical mirobiology</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Kirana Bhatt</p>\n </td>\n <td>\n <p>\n Consultant Physician</p>\n </td>\n <td>\n <p>\n MBChB, MMed internal medicine, MSc clinical tropical medicine, PhD</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gina Ouattara</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB</p>\n </td>\n <td>\n <p>\n 5.5</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gaudensia Mutua</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB, MPH</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Emmanuel Museve</p>\n </td>\n <td>\n <p>\n Study clinician</p>\n </td>\n <td>\n <p>\n Diploma clinical medicine and surgery</p>\n </td>\n <td>\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jacquelyn Nyange</p>\n </td>\n <td>\n <p>\n Study coordinator - regulatory</p>\n </td>\n <td>\n <p>\n KRN, BA psychology, MSc clinical psychology</p>\n </td>\n <td>\n <p>\n 11</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Elizabeth Mutisya</p>\n </td>\n <td>\n <p>\n Study coordinator – clinic level</p>\n </td>\n <td>\n <p>\n KRCHN, BA psychology and sociology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Hilda Ogutu</p>\n </td>\n <td>\n <p>\n Senior study nurse</p>\n </td>\n <td>\n <p>\n KRM, KRCHN, BScN</p>\n </td>\n <td>\n <p>\n 13</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Ndambuki</p>\n </td>\n <td>\n <p>\n Study nurse</p>\n </td>\n <td>\n <p>\n KRCHN, HND counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Roselyne Malogo</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n KRCHN, certificate in conflict resolution, BA community development</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Mahira</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n ECN, diploma in counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Bashir Farah</p>\n </td>\n <td>\n <p>\n Laboratory manager</p>\n </td>\n <td>\n <p>\n HND virology, MSc Virology</p>\n </td>\n <td>\n <p>\n 18</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jackton Indagasi</p>\n </td>\n <td>\n <p>\n Laboratory quality assurance manager</p>\n </td>\n <td>\n <p>\n PGD infectious disease, MSc infectious disease</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Robert Langat</p>\n </td>\n <td>\n <p>\n Laboratory and site Safety officer</p>\n </td>\n <td>\n <p>\n BSc medical laboratory technology</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Simon Ogolla</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n HND microbiology</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Irene Mwangi</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n Diploma laboratory technology, BSc laboratory technology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Ruth Chirchir</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n BSc biological sciences</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Moses Muriuki</p>\n </td>\n <td>\n <p>\n Data/IT Manager</p>\n </td>\n <td>\n <p>\n BSc software engineering</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Laura Lusike</p>\n </td>\n <td>\n <p>\n Data assistant</p>\n </td>\n <td>\n <p>\n BA home economics</p>\n </td>\n <td>\n <p>\n 14</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Other staff:</p>\n <p>\n Administrative, Finance and support staff</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n Site facilities:<br />\n - Reception<br />\n - Waiting room for volunteers<br />\n - Counseling rooms - 2<br />\n - Patient examination rooms – 3<br />\n - Study records filing room – limited access using swipe card<br />\n - Laboratories – swipe access<br />\n o safety laboratory<br />\n o immunology laboratory<br />\n - Data room – limited access with swipe card<br />\n o Pre – archive room – swipe card access<br />\n o Data entry computers – 4<br />\n o Online and offline data entry capabilities<br />\n o Data faxing<br />\n o Internet – upload and download bandwidth of 1MB/second and backup modems from mobile service providers<br />\n o Backup UPS of 4 – 6 hours and backup generator<br />\n - Kitchenette – for staff and volunteer refreshments<br />\n - Meeting room<br />\n Emergency facilities:<br />\n - One of the patient examination rooms is equipped as an emergency room with oxygen tank and mask, suction pump machine with suction tubes, defibrillator, nebulizer, laryngoscope, endotracheal tubes, airway, adult ambu bag and mask, giving sets.<br />\n - Emergency stretcher<br />\n - Emergency drugs in stock –<br />\n o Parenteral - hydrocortisone, adrenaline, paracetamol, hyosine, atropine, lidocaine, lignocaine, aminophylline, sodium bicarbonate, metoclopramide, diazepam, chlorpheniramine, calcium gluconate,<br />\n o Salbutamol nebulizer solution<br />\n o IV fluids – 5% dextrose, 50% dextrose, normal saline<br />\n o Post exposure prophylaxis – combivir and kaletra<br />\n - Patients can then be transferred to Kenyatta National Hospital emergency department or admitted to the wards for further care.</p>\n
      • other_details_explanation<p>\n In this trial we ai to investigate the potentail of using varicella-zoster virus (VZV) as a vector for an hiv-vaccine by first characterising the mucosal immune response induced by VZV vaccination. As we intend to conduct the future VZV-HIV phase 1 clinical trial ( with VZV carrying HIV genes) in kenya it is important that the study that sets the basis for this future be also conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Toronto research ethics committee, !st Dec 2014.</p>\n
      • other_details_regulatory_approved<p>\n KNH/UON Ethics research committee.</p>\n<p>\n Approval date:23rd oct 2014.</p>\n<p>\n Sites: KAVI-ICR, Nairobi Kenya.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration13 months after enrollment.
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI-INSTITUTE OF CLINICAL RESEARCH (KAVI-ICR)
      • single_site_physical_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya.
      • single_site_contact_personProfessor Walter Jaoko,
      • single_site_telephone+254-2-2717694/+254727555254
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listKENYA\nCANADA
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide44
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf Walter Jaoko
      • investigator1_middle_name
      • investigator1_family_name Jaoko
      • investigator1_qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
      • investigator1_professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
      • investigator1_telephone+254-2-2717694/+254727555254
      • investigator1_emailwjaoko@kaviuon.org
      • organisations_transferred_Yes
      • number_participants44
      • notification<p>\n none.</p>\n
      • approval_date10-03-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-01-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-04-26 16:23:36
      • created2015-01-15 09:38:39
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id256
        • application_id376
        • given_nameProf Walter Jaoko
        • middle_name
        • family_nameJaoko
        • qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
        • professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
        • telephone+254-2-2717694/+254727555254
        • emailwjaoko@kaviuon.org
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
    • SiteDetail(array)
      • 0(array)
        • id307
        • application_id376
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id194
        • application_id376
        • sponsorUniversity of Toronto
        • sponsor_type(null)
        • contact_personDr. Kelly S. MacDonald, MD, FRCPC, Chief Investigator
        • addressDepartment of Medicine and Immunology University of Toronto 1 King’s College Circle Medical Sciences Building, Room 6360 Toronto ON, M5S 1A8 Canada.
        • telephone_number(416) 946-3733
        • fax_number(416) 978-8765
        • cell_number(416) 946-3733
        • email_addresskelly.macdonald@utoronto.ca
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
  • 1(array)
    • Application(array)
      • id1114
      • user_id73
      • trial_status_id7
      • abstract_of_study<p>\n <em><strong>PROTOCOL ABSTRACT/SUMMARY</strong></em></p>\n<p>\n Pre-exposure prophylaxis (PrEP) using co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) is a potent HIV prevention method for men and cisgender women., with its Eefficacy is highly dependent on adherence. Pivotal studies that combined clinical epidemiology and pharmacology defined thresholds for PrEP protection in men who have sex with men (MSM) that have been key to PrEP promotion and development of new PrEP agents. For African cisgender women at risk for HIV, a priority group due to disproportionately high incident HIV infections, variable adherence in PrEP clinical trials and limited pharmacokinetics data have resulted in lack of clarity about levels of PrEP use required for HIV protection. A new form of tenofovir, tenofovir alafenamide fumarate, co-formulated with emtricitabine (TAF-FTC) or Descovy® has recently been approved by the U.S. Food and Drug Administration for PrEP use in men. However, Descovy® is not indicated in at risk cisgender women because itsthe safety and effectiveness in this population has not been evaluated. Studies are now planned or ongoing in African cisgender women to evaluate TAF-FTC for PrEP. Tenofovir-diphospate (TFV-DP) in dried blood spots was critical for interpreting Descovy® study outcomes in the DISCOVER trial, and will again be essential for the planned studies to evaluate the effectiveness of Descovy® for PrEP in women. Thus, clear knowledge of African women-specific adherence-concentration benchmark for TAF-FTC relationship is essential to define success of these studies. To date, nNo study has evaluated safety and directly observed expected TAF-FTC PrEP concentrations in African cisgender women with varying frequency of PrEP adherence. TAF efficiently achieves higher concentrations within lymphoid cells while attaining lower TFV concentration in plasma compared to TDF. This creates potential advantages of TAF for PrEP, as the higher TFV-DP in lymphoid cells may confer high activity, whereas the lower plasma TFV concentrations may improve markers of bone and renal changes compared with TDF. Although, the clinical significance of these marker changes is unknown, it is thought that TAF may exhibit improved long-term safety compared with TDF. We will conduct an open-label, randomized, three-arm, directly observed dosing pharmacokinetics study of TAF-FTC PrEP in African cisgender women. The primary objectives are: 1) To assess the safety of TAF-FTC PrEP in cisgender women. 2) To define the cisgender women-specific expected blood concentrations and dose-proportionality for TFV-DP in DBS and PBMCs using directly observed TAF-FTC therapy at 2, 4, 7 doses per week. 3) To establish a model to predict adherence rate to TAF-FTC by level of TFV-DP in DBS for cisgender women. HIV-uninfected non-pregnant cisgender women will be randomly assigned to 1 of 3 dosing frequencies of directly observed therapy (DOT) TAF-FTC PrEP: 2, 4, or 7 doses/week, to help differentiaterepresent poor, and modest, and from perfect adherence, respectively. The study will enroll up to 54 18-30 years old HIV uninfected cisgender women at low risk of HIV at Thika site in Kenya. The proposed study will be the first to define TAF-PrEP adherence-blood concentration thresholds for African cisgender women, a priority population for HIV prevention. The findings will guide accurate interpretation of safety, adherence, and efficacy of planned or ongoing HIV prevention trials in African women.</p>\n
      • study_title<p style=\"text-align: center;\">\n Safety and Pharmacokinetics of TAF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender women</p>\n
      • laymans_summary<p>\n <strong>LAY SUMMARY </strong></p>\n<p>\n <em><strong>Title: </strong></em>Safety and Pharmacokinetics of TAF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender women</p>\n<p>\n <em><strong>Lay title</strong></em>: A project to assess the safety and define the expected blood levels of PrEP medications in cisgender women derived from varying number of PrEP doses taken per week.</p>\n<p>\n African cisgender women are disproportionately affected bywith HIV. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy, but variable adherence in PrEP clinical trials among African cisgender women and limited pharmacokinetics data have resulted in a lack of clarity about the degree of PrEP use required for HIV protection in cisgender women. For men who have sex with men, the STRAND and DOT-DBS studies defined the adherence levels to PrEP medication and expected drug concentrations arising from varying directly observed therapy (DOT) doses per week. Those thresholds are today being applied to studies of African cisgender women taking PrEP, and cisgender womenspecific levels associated with HIV prevention have never been defined. However, recent data from large PrEP studies we have done among African cisgender women ─ including the Partners PrEP Study and Partners Demonstration Projects conducted at Thika site, suggest those these levels may not reflect the pharmacology of cisgender women in African settings. In these studies in African populations, however, PrEP dosing was not directly observed therapy; and no study has established expected PrEP concentrations in African cisgender women with varying frequency of PrEP adherence. Thus, there is an urgent need to define the frequency of adverse events, adherence and expected blood concentrations of PrEP medications in cisgender women. </p>\n
      • short_titleThe Women TAF-FTC Benchmark
      • protocol_noECCT/22/02/02
      • version_no1.0
      • date_of_protocol15-08-2021
      • study_drugTenofovir Alafenamide Fumarate/Emtricitabine - TAF/FTC (25/200mg) - Descovy®
      • disease_conditionHIV Prevention
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTAF/FTC
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr. Nelly Rwamba Mugo
      • declaration_date123-02-2022
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date223-02-2022
      • placebo_presentNo
      • study_objectives<p>\n <strong>The primary objectives of this study are;</strong></p>\n<ol>\n <li>\n To describe the safety of TAF-FTC-based PrEP in HIV-uninfected cisgender women.</li>\n <li>\n To define the cisgender women-specific expected blood concentrations and dose proportionality for TFV-DP in DBS and PBMCs in cisgender women using directly observed TAF-FTC therapy at 2, 4, 7 doses per week.</li>\n <li>\n To establish a model to predict adherence rate to TAF-FTC by level of TFV-DP in DBS for cisgender women.</li>\n</ol>\n<p>\n  </p>\n<p>\n <strong>Secondary Objectives</strong></p>\n<ol>\n <li>\n To define the expected concentrations and dose-proportionally for TFV-DP in PBMC and vaginal tissue</li>\n <li>\n To eExamine relationships among drug concentrations in plasma, WB, DBS, and PBMC.</li>\n <li>\n To determine the influence of biological variables (e.g., HCT, age, weight, sex, metabolites from metabolomics, and genetic variability in drug transporter/clearance proteins) on drug concentrations.</li>\n <li>\n To cCompare drug concentrations in DBS from fingerstick versus drug concentrations in DBS transferreding blood from blood tubes.</li>\n</ol>\n
      • principal_inclusion_criteria<p>\n <strong>Inclusion Criteria</strong></p>\n<p>\n This study will enroll young Kenyan cisgender women (aged 18-30 years old). Cisgender women bear the greatest burden for HIV infection; thus, the study will focus solely on cisgender women. HIV incidence is greatest in younger cisgender women ages 15-24, as is PrEP interest in accumulating PrEP data from Kenya. The, and the age limitation on enrollees into the study reflects that clinical and epidemiologic need. Enrollment criteria will be finalized at the time of protocol development to account for any updates to Kenyan national guidelines, but the central clinical criteria are as follows:</p>\n<p>\n <strong>For all cisgender women;</strong></p>\n<p>\n - Age ≥18 and ≤30 years old.</p>\n<p>\n - Willing to undergo urine pregnancy tests.</p>\n<p>\n - Has understood the information provided and has provided written informed consent before any study-related procedures are performed.</p>\n<p>\n - HIV uninfected based on negative HIV rapid tests, according to Kenyan national algorithm.</p>\n<p>\n - Normal renal function (estimated glomerular filtration rate >60 mL/min). - Hepatitis B surface antigenAg negative.</p>\n<p>\n - No active, clinically significant medical or psychiatric conditions that, in the opinion of the investigators, would interfere with study participation .</p>\n<p>\n - Lack of severe anemia (Hemoglobin >10 g/dL).</p>\n<p>\n - Willing to use DOT and come to clinic frequently for DOT PrEP for at least 10 weeks.</p>\n<p>\n - Willing to have home visits for follow up.</p>\n<p>\n - Has access to an active smartphone to allow off-site observation of dosing if unable to come to the clinic, or, as determined by the study staff, the participant resides in a close enough location to the clinic to permit a home visit if unable to come to the clinic. That isi.e., potential participants without a smatphone may be enrolled in the study if investigator determines that the particiapant resides within reasonable distance from the clinic that would permit home visit id the participant misses their visitfor a home visit in the case of a missed clinic visit.</p>\n<p>\n - Intention to stay within the study site’s catchment area for at least 10 weeks. </p>\n<p>\n - Resides or works in catchment area with high speed internet coverage to permit video streaming.</p>\n<p>\n - Not pregnant or breast feeding.</p>\n<p>\n - Willing to use effective contraception during the study period.</p>\n<p>\n - At low risk for HIV. In Kenya, national guidelines define substantial risk for HIV and recommend PrEP be an option for individuals reporting: partner of HIV-infected person not on ART or on ART for <6 months, >1 partner of unknown status, transactional sex, recent STI, recurrent PEP use, inconsistent condom use, or injection drug use. So, non-pregnant cisgender women reporting any of these factors will not be eligible for the study but will be linked for PrEP at clinic of choice including at Thika Site itself. - Willing to be randomized to non-daily PrEP and to come to the clinic frequently for DOT PrEP. - Willingness and ability to be abstinent for at least 7 days after each vaginal biopsy visit.</p>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion Criteria For all cisgender women;</strong></p>\n<p>\n – Inability to give informed consent</p>\n<p>\n – Positive screening HIV+ as determined by standard rapid serologic assays or suspected acute HIV infection in the opinion of the clinician. (Eexample signs and symptoms of acute HIV infection include combinations of fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and cervical or inguinal adenopathy cervical or inguinal.)</p>\n<p>\n – Positive HBV surface antigen test at screening.</p>\n<p>\n – Calculated creatinine clearance <60 ml/min.</p>\n<p>\n – Any laboratory value or uncontrolled medical conditions that, in the opinion of the investigators, would interfere with the study conditions such as, heart disease and/or cancer.</p>\n<p>\n – Prohibited concomitant medications are: investigational agents (within 30 days of enrollment), aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or >500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, TRUVADA®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.</p>\n<p>\n – Current or past use of PrEP (pre-exposure prophylaxis).</p>\n<p>\n – Not willing to have home visits.</p>\n<p>\n – Pregnantcy or plan to become pregnant in the next 6 months or unwillingness to use birth control .</p>\n<p>\n – Currently breastfeeding.</p>\n<p>\n – High risk of HIV infection (for example: sexually active with an HIV infected partner; engages in condomless intercourse with HIV-infected partners or partner of unknown status during the study; females who exchanges sex for money, shelter, or gifts; active injection drug use or during the last 12 months; newly diagnosed sexually transmitted infections in last 6 months. </p>\n
      • primary_end_points<p>\n S<strong>tudy endpoints;</strong></p>\n<p>\n <strong> </strong>• Aim 1: Mean, variance, and dose proportionality for TFV-DP or TFV in plasma, DBS, and PBMC for 2, 4, 7of DOT TAF-FTC dosing per week.</p>\n<p>\n • Aim 2: Prediction model of adherence rate by level of TFV-DP in DBS.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n  </div>\n<div>\n <p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n KEMRI-CCR Partners in Health & Research Development - PHRD (Formerly Partners in Prevention) Thika Project, has 64 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc).</p>\n <p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n <p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Principal Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n <p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n                                       </p>\n <p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Coordinator: Dr. Catherine Kiptinness, BPharm, MPH</p>\n <p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Regulatory Lead: Peter Mogere, DPharm., B.Sc</p>\n <p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Study Coordinator: Dr. Matilda Saina MBChB</p>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Disproportionate risk for HIV among African cisgender women;</strong> More than 600 000 new HIV infections occur annually among young African cisgender women, and thewith incidence rates are often double or more than those among their male age-mates. A recent clinical trial in eastern and southern Africa (the ECHO Study) that evaluated the risk of HIV acquisition in HIV-negative cisgender women who used three common contraceptive methods found that HIV incidence among sexually active cisgender women was alarmingly high ─ oan average nearly 4% ─ with higher rates of HIV infection for cisgender women <25 years irrespective of the contraceptive method. Thus, these recent results have reminded usemphasize that HIV remains a significant personal risk and public health challenge for many cisgender women in African countries. Evidence of TDF/FTC PrEP efficacy and relationship to adherence FTC/TDF PrEP is a highly efficacious and safe strategy for reducing HIV risk among men who have sex with men , heterosexual men and women, and injection drug users , and is now recommended as a prevention option for all persons at high risk for acquiring HIV. There was variation in HIV protection aAcross first generation FTC/TDF PrEP trials, there was variations in HIV protection  , and pharmacokinetics measurements as markers of adherence have transformed our understanding of FTC/TDF PrEP adherence and efficacy. In the Partners PrEP Study, which included 1,785 East African women with a mutually disclosed HIV-infected partner, PrEP efficacy among cisgender women was 66% for TDF and 71% for FTC/TDF PrEP vs placebo , and the protective effect was consistent in subgroups of cisgender women at high risk for HIV acquisition. In the TDF2 study in Botswana, PrEP efficacy among cisgender women was 49%, but interpretation was limited by the small sample size. However, the enthusiasm for PrEP use in cisgender women faltered after the FEM PrEP and VOICE trials failed to demonstrate efficacy. While there were initially several potential explanations for the failure of PrEP in these two trials, including behavior and biologic factors, the consensus settled on poor adherence.</div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>A new form of tenofovir for PrEP</strong></div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n A new form of tenofovir for PrEP Based on the DISCOVER trial evaluated the safety and efficacy tenofovir alafenamide fumarate coformulated with emtricitabine (F-TAF) (Descovy®) is approved by the U.S. Food and Drug Administration for PrEP use in men. This randomized, double-blind multinational trial, enrolledThe safety and efficacy of Descovy® for PrEP were evaluated in a randomized, double-blind multinational trial in 5,387 HIVnegative men and transgender women who have sex with men and were at risk of HIV-1 infection to , and compared once daily Descovy® to Truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg). Following the trial, Descovy® was approved by the U.S. Food and Drug Administration for PrEP use in men. However, Descovy® is not yet indicated in at risk cisgender women because the effectiveness in this population has not been evaluated. Studies are now ongoing in African cisgender. Graphical presentation how PrEP efficacy varied by adherence across PrEP trials (credit AVAC) women to evaluate F-TAF (TAF-FTC) for PrEP. For persons with HIV, Descovy® has been approved for FDA for treatment of HIV in combination with other antiretroviral drugs since 2016. </div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <em><strong>Pharmacology of TFV and TFV-DP in African cisgender women</strong> </em></div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n For African women at risk for HIV, variable adherence in PrEP clinical trials and limited data for TFV-DP in DBS have resulted in lack of clarity about levels of PrEP use required for HIV protection. Indeed, the absence of robust pharmacokinetics data for cisgender women, particularly studies that link adherence to expected concentrations in women, helped prevent the TAF-FTC indication for HIV prevention to be extended to cisgender women. Recent data from large FTC/TDF PrEP studies we have done among women, including the IMPAACT 2009 Study, indicate that the pharmacology of FTC/TDF in DBS in women in African settings may be different from that inof USA settings, in general and particularly in pregnancy where TFV-DP concentrations may be reduced by 30-40% women.</div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" margin-left:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n
      • other_details_regulatory_notapproved<p>\n <span style=\"color: rgb(51, 51, 51); font-family: arial, helvetica, sans-serif; font-size: 14px;\">University of Washington IRB</span></p>\n
      • other_details_regulatory_approved<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 14px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Kenya Medical Research Institute</span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 14px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Approval date: 21/01/2022</span></span></p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration2 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-CCR PHRD Thika
      • single_site_physical_addressThika section 9,AOU Road, near Thika Nursing home
      • single_site_contact_personDr. Nelly Mugo Rwamba
      • single_site_telephone+254 722362219
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide54
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameKENNETH
      • investigator1_middle_nameN/A
      • investigator1_family_nameMUGWANYA
      • investigator1_qualificationMBChB, MS, PhD
      • investigator1_professional_addressBox 359927 325 Ninth Ave, Seattle, WA 98104
      • investigator1_telephone+1-206-520-4245
      • investigator1_emailmugwanya@uw.edu
      • organisations_transferred_Yes
      • number_participants54
      • notification<p>\n None</p>\n
      • approval_date18-11-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-03-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been responded to adequately.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-02-27 17:22:19
      • created2022-02-08 13:20:27
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id791
        • application_id1114
        • given_nameDr. Nelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MMeD, MPH
        • professional_addressKEMRI-CCR
        • telephone+254722823770
        • emailrwamba@uw.edu
        • created2022-02-08 13:23:02
        • modified2022-03-22 10:24:32
    • SiteDetail(array)
      • 0(array)
        • id1241
        • application_id1114
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-02-08 13:23:02
        • modified2022-03-22 10:24:32
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id575
        • application_id1114
        • sponsorUNIVERSITY OF WASHINGTON
        • sponsor_typeOthers
        • contact_personDr. Nelly Mugo Rwamba
        • addressKEMRI-CCR PHRD Thika clinical trial site
        • telephone_number+254 722823770
        • fax_number
        • cell_number+254 722823770
        • email_addressrwamba@uw.edu
        • created2022-02-08 13:23:02
        • modified2022-03-22 10:24:32
  • 2(array)
    • Application(array)
      • id833
      • user_id567
      • trial_status_id5
      • abstract_of_study<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Background</b>:  Kenya has the 4th largest HIV burden in the world with about 1.6 million people living with HIV.  Of these, just over 1 million are on antiretroviral therapy.  Current national guidelines recommend a first line regimen composed of 2 nucleoside reverse transcriptase inhibitors (NRTI) plus an integrase strand transfer inhibitor (INSTI) or a non-nucleoside reverse transcriptase inhibitor(NNRTI).  Second line regimens are composed of 2 NRTI plus a ritonavir boosted protease inhibitor(PIr).  This is based on evidence showing good clinical outcomes on this regimen.  Protease inhibitors are associated with multiple side effects including an increase is cardiovascular disease risk and, have significant drug to drug interactions that complicate management of other conditions such as tuberculosis.  INSTIs have been shown in one study to be an alternative to PIr in second line regimens when combined with fully active NRTIs.  It is not clear if this would still be the case if the activity of the NRTIs was not known.  We will evaluate the efficacy of switching from a PIr to a dolutegravir based second line ART regimen.</span></p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 14px;\">\n  </p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Hypothesis</b>: switching virologically suppressed patients from a PIr based second line to a dolutegravir based second line is non-inferior to continuing on a PIr based second line.</span></p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 14px;\">\n  </p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Objectives</b>: The primary objective will be to evaluate the non-inferiority of switching to a DTG containing regimen relative to maintaining a PI/r containing second-line regimen in virologically suppressed, INSTI-naive HIV-1 positive adults (≥ 18 years old) as determined by having HIV-1 RNA ≥ 50 copies/ml at week 48.  Secondary objectives will be to assess the impact of such a switch on CD4 counts, safety and tolerability.</span></p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 14px;\">\n  </p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Methods</b>: Open-label, randomized, non-inferiority, multisite trial over 48 weeks, describing the efficacy and safety of switching from a second-line ARV regimen containing a ritonavir-boosted protease inhibitor (PI/r) plus 2 NRTIs to DTG plus 2 NRTIs in patients having achieved virological suppression (HIV-1 RNA < 50 copies/ml) for at least 12 weeks and with no prior INSTI exposure.  Adult consenting participants will be randomized at baseline to remain on their pre-enrollment PI/r or switch to DTG.  Participants will continue the NRTIs from their pre-enrollment regimen in both arms.  A total of 766 participants (388 in each arm) will be recruited from 4 sites - Kenyatta National Hospital, Kiambu County Hospital, Thika County Hospital and Jaramogi Oginga Odinga Teaching and Referral Hospital.</span></p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 13px;\">\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Conclusion:</b> This study seeks to inform the guidelines around the efficacy and safety of alternative second line regimens.</span></p>\n
      • study_title<p style=\"margin: 0px; text-align: center; font-stretch: normal; line-height: normal; font-family: "Trebuchet MS"; -webkit-text-stroke-width: initial; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"font-kerning: none\"><b>Switching Treatment-Experienced, Integrase Inhibitor-Naïve, Virally Suppressed HIV-1 Infected Adults from Ritonavir boosted Protease Inhibitors to Dolutegravir: An Open-Label Randomized Controlled Trial</b></span></p>\n<p style=\"margin: 0px; text-align: center; font-stretch: normal; line-height: normal; font-family: "Trebuchet MS"; -webkit-text-stroke-width: initial; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 14px;\">\n  </p>\n<p style=\"margin: 0px; text-align: center; font-stretch: normal; line-height: normal; font-family: "Trebuchet MS"; -webkit-text-stroke-width: initial; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n  </p>\n<div>\n  </div>\n
      • laymans_summary<p>\n <strong>Background</strong></p>\n<p>\n People living with HIV are given medication to reduce (suppress) the amount of the virus in their blood called antiretroviral drugs (ARVs). Suppressing the virus results in improved immunity, reduction in sickness and reduced chances of transmission of the virus. However, these ARVs have to be taken for life to maintain suppression. However, in some cases, the first set of ARVs given may become ineffective in suppressing the virus necessitating a change to another option of drugs which is referred to as second line therapy. Just like any other medication, ARVs have side effects with some of the drugs used in second line therapy having more side effects than those used in the nationally recommended first-line therapy.</p>\n<p>\n Over time, newer safer and easier to take ARVs have been made. The purpose of this study is to determine whether patients who are currently on the standard national second line therapy can be safely switched to a regimen containing one of the newer ARVs called dolutegravir. This is important because some studies have shown us that dolutegravir may achieve the same or better rates of viral suppression, may have less harmful effects to the body including improving cholesterol and may be simpler to take.</p>\n<p>\n Dolutegravir is not a new drug, it has been used in this country for the last 4 years and is the recommended drug for first line HIV treatment (this is the very first regimen or HIV treatment one uses after a diagnosis of HIV).  It has not routinely been used for second line treatment in Kenya yet. Dolutegravir is a tablet that is swallowed. It can either be combined with other drugs in to one pill or be provided as a separate pill.</p>\n<p>\n <strong>What questions are we trying to answer?</strong></p>\n<p>\n Sometimes we do not always know which drugs work best for different patients. To find out, we need to make comparisons between the different treatments. We put people into groups and give each group a different treatment; the results are compared to see if one is better. The areas we will assess at the end of this study are:</p>\n<ul>\n <li>\n Whether viral load will continue to be suppressed or will increase</li>\n <li>\n Change in CD4 count</li>\n <li>\n Change in lipid (cholesterol) levels</li>\n <li>\n Change in blood glucose</li>\n <li>\n Change in weight, body-mass index, waist-hip ratio and, waist circumference</li>\n <li>\n Whether any side effects are experienced</li>\n <li>\n How satisfied participants are with their treatment</li>\n <li>\n If the viral load is not suppressed, whether the virus develops any resistance</li>\n</ul>\n<p>\n At the end of the study, we will determine whether these areas are equal in the study arms or whether one arm is better or worse than the other. This will help inform our knowledge and guidelines on management of second line antiretroviral therapy.</p>\n<p>\n <strong>Where will the study be done?</strong></p>\n<p>\n This study will take place at Kenyatta National Hospital, Thika Level V Hospital, Kiambu County Hospital and Jaramogi Oginga Odinga Teaching and Referral Hospital.</p>\n<p>\n <strong>How will the study be conducted?</strong></p>\n<p>\n Those currently on care at the study sites who are on second line treatment will be invited for a screening visit to review whether they can participate in the study. This will involve review of their medical history and laboratory tests. Those who are eligible for the study will either be given a new treatment combination containing dolutegravir or continue their treatment regimen without any change. For this study, the chances of being enrolled into one or the other arm is 1 in 2. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly, this is what we call randomisation). 766 people living with HIV will be recruited in this study. Each participant will be followed up for up to 1 year, during which there will be at least five additional clinic visits on weeks 4, 12, 24, 36 and 48 from the enrollment visit. The results for the two groups will then compared. </p>\n<p>\n We expect that it will take about 18 months for all the 766 participants to go through 1 year of follow-up.</p>\n<p>\n  </p>\n
      • short_titleSecond line switch to Dolutegravir (2SD) study
      • protocol_noECCT/19/11/04
      • version_no2.3
      • date_of_protocol18-11-2019
      • study_drugDolutegravir
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDolutegravir
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameBoosted Atazanavir and Lopinavir
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressloisea@uonbi.ac.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Loice Achieng
      • declaration_date118-11-2019
      • declaration_principal_investigatorDr. Loice Achieng
      • declaration_date218-11-2019
      • placebo_presentNo
      • study_objectives<p>\n Primary Objective</p>\n<ul>\n <li>\n To evaluate the non-inferiority of switching to a DTG containing regimen relative to maintaining a PI/r containing second-line regimen in virologically suppressed, INSTI-naive HIV-1 positive adults (≥ 18 years old) as determined by having HIV-1 RNA ≥ 50 copies/ml at week 48.</li>\n</ul>\n<p>\n Secondary Objectives</p>\n<ul>\n <li>\n To assess the impact of switching to DTG on development of virological failure at week 24</li>\n <li>\n To assess the impact of switching to DTG on maintenance of virological suppression at weeks 24 and 48</li>\n <li>\n To assess the impact of switching to DTG on change in CD4 count at weeks 24 and 48</li>\n <li>\n To assess the impact of switching to DTG on change in cardiovascular risk as determined by change in lipid values (total cholesterol, LDL, HDL, triglycerides and TC:HDL ratio) at weeks 24 and 48 and change in fasting blood glucose at weeks 24 and 48</li>\n <li>\n To investigate the impact of switching to DTG on change in anthropometric measurements (weight, body-mass index, waist-hip ratio, waist circumference)</li>\n <li>\n To investigate the impact of switching to DTG on safety and tolerability</li>\n <li>\n To investigate the impact of switching to DTG on patient satisfaction, as determined by the HIV Treatment Satisfaction Questionnaire (HIVTSQ)</li>\n <li>\n To investigate if outcomes differ based on the PI/r used (LPV/r, ATV/r, or DRV/r)</li>\n <li>\n To investigate if outcomes differ based on the NRTI used (TDF, ABC, or AZT)</li>\n <li>\n To investigate if outcomes differ for patients who switch NRTIs for clinical reasons during the study relative to patients who do not switch NRTIs during the study</li>\n <li>\n To investigate if outcomes differ based on if the NRTIs were changed from first-line to second-line</li>\n <li>\n To describe the genotypic resistance patterns for participants meeting protocol-defined virological failure</li>\n</ul>\n
      • principal_inclusion_criteria<p style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \">\n <span style=\"font-kerning: none\">Participants must satisfy all of the following criteria to be enrolled in the study:</span></p>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Able and willing to understand and comply with the protocol requirements, instructions and restrictions</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Able and willing to give informed consent</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Age 18 years or above</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Documented HIV-1 infection as confirmed by HIV-antibody testing as per the Kenya National Guidelines</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Has been receiving a second-line ARV regimen containing a PI/r (DRV/r, ATV/r or LPV/r) and 2 NRTIs for at least 24 weeks</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Documented HIV-1 RNA viral load < 50 copies/ml at least 12 weeks prior to enrollment and no viral rebound between the first viral load < 50 copies/ml and the screening viral load</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">HIV-1 RNA viral load < 50 copies/ml at screening (within 28 days prior to enrollment)</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">If female and of childbearing potential, is using effective contraception and is willing to continue using effective contraception throughout the study period (as defined in Appendix 5). Note: Non-childbearing potential is defined as either post-menopausal (12 months of spontaneous amenorrhoea and age of 45 years or above) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy</span></li>\n</ul>\n
      • principal_exclusion_criteria<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Potential participants who meet any of the following criteria will be excluded from participating in the study:</span></p>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Any prior integrase inhibitor exposure</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Documented HIV-2 infection</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Using any concomitant therapy disallowed as per the reference safety information and product labeling for the study drugs</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Has AST and/or ALT at least 5-times greater than the upper limit of normal in conjunction with hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV). Note: patients can enter the study with chronic HBV or HCV if AST and ALT are less than 5-times greater than the upper limit of normal and, in the investigators opinion, their medical status will not interfere with assessments or completion of the study</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Is both HBsAg positive and has a CrCl below 50 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Advanced renal insufficiency requiring dialysis</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">If female, currently pregnant or breastfeeding, or intending to become pregnant during the study period</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Documented opportunistic infection within 4 weeks prior to the study enrolment</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Investigator opinion that the patient should switch from PI/r to DTG immediately for clinical reasons</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the study</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">History or presence of allergy to the study drugs or their components</span></li>\n</ul>\n
      • primary_end_points<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\"><b>Primary Endpoint:</b></span></p>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Proportion of participants with HIV-1 RNA ≥ 50 copies/ml at week 48 (by US Food and Drug Administration snapshot algorithm, modified to allow for changes in NRTIs for clinical reasons)</span></li>\n</ul>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\"><b>Secondary Endpoints:</b></span></p>\n<p>\n  </p>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Proportion of participants with HIV-1 RNA ≥ 50 copies/ml at week 24</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Proportion of participants able to maintain virological suppression (HIV-1 RNA < 50 copies/ml with no discontinuation of the study treatment) at weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Change in CD4 count from baseline to weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Change in fasting blood sugar and lipid values (total cholesterol, LDL, HDL, triglycerides and TC:HDL ratio) from baseline to weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Change in anthropometric measurements (weight, body-mass index, waist-hip ratio, waist circumference) from baseline to weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Safety (clinical and laboratory adverse events) at weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Patient satisfaction (HIVTSQ) at weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Genotypic resistance mutations for participants with protocol-defined virological failure</span></li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\"><b>CAPABILITY STATEMENT FOR KNH COMPREHENSIVE CARE CENTRE TO CONDUCT CLINICAL RESEARCH</b></span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Kenyatta National Hospital Comprehensive Care Centre was established in December 2002 as the pioneer care and treatment Centre for HIV/AIDS. The Centre was established with the support of the USAID/FHI/KNH cooperative agreement with the main objective of mitigating the effects of HIV/AIDS nationally by participating in the national HIV/AIDS response. Since 2005, services and expansion of the Centre have been supported by Center for Disease Prevention and Control (CDC) through the University of Nairobi, AIDS Care and Treatment Services (ACTS),Partnership for Advanced Care and Treatment – Centre of Excellence (PACT - CoE) and Centers’ of Excellence - HIV Medicine (CoEHM) Programs respectively. It has evolved over time to be a Centre of excellence for ambulatory HIV medicine in the country dealing with both complicated referral patients and stable patients.  </span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">The comprehensive care centre offers a one stop shop approach in the management of HIV/AIDS. In order to achieve this goal, a multidisciplinary team with different specializations in HIV/AIDS management runs the centre. This team consists of Consultants, Medical Specialists, Medical Officers, Registered Clinical Officers, Pharmacists and Pharmaceutical Technologists, Counsellors, Laboratory Staff, Nursing Officers, Nutritionists and social workers among others.</span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">The services offered at the Comprehensive Care Centre include the following:</span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<ol>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Diagnosis and Treatment of opportunistic infections and other HIV/AIDS related co- morbidities.</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Anti-Retroviral Therapy both 1</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^st</span><span style=\"font-kerning: none\"> line; 2</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^nd</span><span style=\"font-kerning: none\"> line and 3</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^rd</span><span style=\"font-kerning: none\"> line regimens as per the WHO guidelines.</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Laboratory monitoring and evaluation of the patients- The Centre has an ISO 15189:2012 standard accredited laboratory which has equipment that can do the following analytical procedures:</span></li>\n</ol>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Flow Cytometry </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Hematology </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Chemistry </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">TB Diagnosis </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">HIV EID </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">HIV Viral Load </span></li>\n</ul>\n<ol>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Research: Since its inception the Centre has actively been involved in research which has informed HIV/AIDS National policy. Some of the research conducted in the facility by both the University of Nairobi and Kenyatta National Hospital in collaboration with International partners include: </span></li>\n</ol>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Effectiveness of Non-nucleoside Reverse-Transcriptase Inhibitor-Based Antiretroviral Therapy in Women Previously Exposed to a Single Intrapartum Dose of Nevirapine:  A Multi-country, Prospective Cohort Study</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Optimizing Pediatric HAART Study</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Evaluation of the Kenya ARV scale-up program:  Surveillance for emergence of antiretroviral resistant genotypes among treatment experienced patients</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Treatment outcomes of HIV infected adolescents attending a National Referral Hospital in Kenya:</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Trends, treatment outcomes and determinants of attrition among adult patients in care in a large tertiary HIV clinic in Nairobi Kenya</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Predicted HIV-1 co receptor usage among Kenya patients shows a high tendency for subtype d to be cxcr4 tropic</span></li>\n</ul>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<ol>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Training of undergraduate and  post graduate students in the departments of Medicine and Pediatrics from the University of Nairobi</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Adherence Counseling</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Nutritional Counseling</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Social Work Support</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Physiotherapy services</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Supportive Counseling.</span></li>\n</ol>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">The CCC currently serves an average of 150-200 patients per day. Currently, adult patients on ART are 9400 with 8,150 on 1</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^st</span><span style=\"font-kerning: none\"> line regimens and 1,230 on 2</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^nd</span><span style=\"font-kerning: none\"> line regimen and 20 patients on 3</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^rd</span><span style=\"font-kerning: none\"> line regimen.</span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">With the experience of the staff working in the CCC and the high number of patients, the KNH Comprehensive Care Centre is best suited to undertake any kind of research </span></p>\n<p>\n  </p>\n<div>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-stretch: normal; line-height: normal; font-family: Times; -webkit-font-kerning: none;\">Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH), </span><span style=\"font-kerning: none\">formerly known as New Nyanza Provincial General Hospital or Russia was built in 1965 by the Russian Government (then Soviet Union) through the Government of Kenya. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The hospital has been named Jaramogi Oginga Odinga in honour of one of the founding fathers of this Nation, Jaramogi Oginga Odinga who played a pivotal role in convincing the Russian Government to fund and build the facility. Henceforth, the hospital will be known as Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH). </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">JOOTRH has been in operation since 1969. It is located in Kisumu city on acreage of 22.6 hectares along Kisumu - Kakamega highway. It is the main referral centre to 10 counties in western Kenya and rift valley with a population of more than 7 million people. It has a bed capacity of 530. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The main mandate of JOOTRH is to provide curative, preventive, promotive and rehabilitative health services. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">It provides specialized clinical services in the areas of renal medicine, critical care, oncology, orthopaedic surgery, paediatric surgery and specialized diagnostic services—both radiological and laboratory services. It serves as a centre for research activities, medical training for midlevel health workers and medical students for Maseno University and Uzima university. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The hospital has a total of 640 staff consisting of 486 regular staff, 154 donor-supported staff (for HIV care services) as at 1st June 2019.</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">JOOTRH CCC was started in the year 2002 and has ever enrolled approximately 28000 clients. Current active on care is 6842 by the end of June 2019. Total number of clients on 1</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^st</span><span style=\"font-kerning: none\"> line are 6203 , on 2</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^nd</span><span style=\"font-kerning: none\"> line are 600, and 11 clients are on 3</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^rd</span><span style=\"font-kerning: none\"> line. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">Out of The 154 staff employed by ICAP who is the implementing partner, 39 are stationed at the CCC and 6 are MOH staff.. 1 Medical officer, 1 pharmacist, 8 nurses,7 clinical officers ,3 Pharmacy technicians, 2 social workers,4 adherence councilors, 8 peer educators, 3 HRIOs, 5 data clerks, 1 nutritionist and 1 lab technician.</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The daily workload of the clinic is between 250- 300 (MON, TUE, FRI), adults (35 yrs and above), 180 – 250 clients seen on Wednesday (youth day age 20- 35 yrs), 70 – 150 clients on Thursdays (adolescents day)</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The CCC also runs a viremia clinics for patient with high viral loads on 1</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^st</span><span style=\"font-kerning: none\"> line every Wednesday and Fridays for clients failing second line treatment.</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The medical officer is the in charge of the clinic and works closely with the Matron and the pharmacist in charge. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The clinic has been integrated and most of the services are offered within CCC which includes, clinical, nursing, adherence counseling, nutrition, community and linkage to OVC, cervical cancer screening amongst others. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">JOOTRH is also the HUB center for Nyanza western technical working group meetings held every 2</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^nd</span><span style=\"font-kerning: none\"> Monday of the month. We are also the spokes hub for ECHO sessions held every Thursday at 3pm.</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; min-height: 14px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n <span style=\"font-stretch: normal; font-size: 12px; line-height: normal;\"> </span><b>Kiambu Level 5 and Thika Level 5 Hospital Profiles </b></p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Kiambu Level 5 Hospital is located within the outskirts of Nairobi, at Kiambu town which is approximately 18km from the capital city. It was established in 1920 and due to its proximity to Nairobi County, the hospital is frequently the first point of service for populations from the sub-counties within Nairobi County that are contiguous with Kiambu County, particularly the parts that are impoverished and marginal. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n The catchment population of Kiambu Level 5 Hospital (KL5H) is currently placed at about 120,000 persons – a figure estimated from the National Census of 2009. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n KL5H has a higher share of emergencies because of its location between the main national trunk roads traversing the County of Kiambu to the Western and Northern parts of the country. These factors make KL5H easily accessible to residents of Kiambu and Nairobi counties, as well as those that experience road traffic emergencies along the national trunk roads. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n The hospital sits on a 10 acres piece of land. It has a bed capacity of 324 beds with bed occupancy of an approximate 154%. The hospital has 1 medical ward (72 beds), 1 surgical ward (72 beds), 1 maternity ward (74 beds), 1 new born unit (53 beds), 1 pediatric ward (57 beds), 2 operating theaters, casualty area, outpatient departments that include a Comprehensive Care Centre, eye clinic unit, dental clinic unit, Ear Nose and Throat (ENT) clinic unit, Central Sterile Supplies Department (CSSD) unit, pharmacy, laboratory, psychiatric clinic unit, physiotherapy unit, occupational therapy unit, radiology department, registry and records unit, kitchen and laundry, maintenance department, administration offices and mortuary. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n During 2016 – 2018, Kiambu Level 5 Hospital received a total of 610,902 outpatient attendances, Additionally, during 2016 – 2018, Kiambu Level 5 Hospital conducted a total of 27,331 deliveries. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n <b>Comprehensive Care Centre </b></p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Kiambu level 5 hospital started its HIV comprehensive Care Centre in August 2005 with a total of 3 patients. The client numbers have grown over the years to a cumulative number of <b>10,732 </b>clients ever enrolled. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Kiambu L5H is currently supported by UON-CRISS+ project in implementation of HIV services. The facility underwent major renovations in 2015, through the support of the implementing partner., The following units were set up within the CCC; Chest clinic, 3 consultation rooms, VCT room, Nutrition room, Health records room, adherence counselling room, Pharmacy, 2 HTS rooms and a cervical cancer screening room. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n The current number of clients on follow up is <b>3,190 </b>and is distributed as follows; </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 330 PMTCT mothers with 258 HEI’s on follow up. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 67 males and 48 females less than 15years. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1008 males and 2067 females above 15years. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; min-height: 13px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n The following staff are supported by CRISSP+ at the CCC; </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 3 Clinicians </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1 adherence nurse </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1 psychologist </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 8 HTS providers </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1 pharmaceutical technologist </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; min-height: 13px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; min-height: 13px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1 lab technician </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 2 HRIO’s </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 3 LCN’s </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; min-height: 13px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n <b>Human Resource </b></p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n As at 31<span style=\"font-stretch: normal; font-size: 7px; line-height: normal;\">st </span>Dec 2018, KL5H had a total of 453 working staff including 93 intern medical officers, pharmacists, nurses, clinical officers and community oral health officers) as seen in Table 1. Another 24 workers were on training leave. Thus, KL5H had only a total of 360 qualified workers against a total of 1,469 workers (24.5%) in accordance with the KEPH Level 5 hospital staffing norms. During 2016 – 2018, KL5H saw a total of 610,902 patients translating to an average 4 times as many patients per health worker as compared to the KEPH Level 5 staffing norms. </p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n  </p>\n <table cellpadding=\"0\" cellspacing=\"0\" style=\"border-collapse: collapse\">\n <tbody>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n <i>Table 1: KL5H Staff Profile As 31st Dec 2018 </i>Consultants 19 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Medical Officers 15 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n General & Specialized Dental Officers 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n General and Specialized Pharmacists & Allied Staff 9 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n General & Specialized Nurses </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 169 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n General and Specialized Clinical Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 23 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Diagnostic & Imaging Staff </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 6 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Rehabilitative Staff </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 14 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Medical Laboratory Scientists </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 10 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Dental Technologists </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Community Oral Health </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Plaster Technicians </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 4 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Medical Social Workers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 3 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Nutritionists & Nutrition Staff </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 6 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Clinical Cytologist </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Clinical Psychologists (counsellor) </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Health Promotion Officer </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Health Administration Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Accountant/Finance Officer </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Clerical Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 10 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Office Administrative Assistant </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Telephone Operators </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 5 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Supportive Staff </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 10 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Cooks </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 4 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Health Records Information Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 5 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Med. Engineering </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 7 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Artisans </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Drivers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 5 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Procurement Officers Incl. Assistants </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 4 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Public Health Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 16 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Data Clerk </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n </tbody>\n </table>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n  </p>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Study is sposored by the University of Nairobi and conducted fully in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KNH-UoN ERC</p>\n<p>\n JOOTRH ethics committee</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration18 months from time of first patient enrolled to last patient follow-up. Each patient is followed up for 48 weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorCurrent Ritonavir boosted
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites4
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site766
      • total_participants_worldwide766
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenUnclear
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLoice
      • investigator1_middle_name
      • investigator1_family_nameAchieng
      • investigator1_qualificationMBChB, MMED Internal Medicine, MSC Infectious Diseases
      • investigator1_professional_addressP.O Box 2304-00202, Nairobi
      • investigator1_telephone+254722576984
      • investigator1_emailloisea@uonbi.ac.ke
      • organisations_transferred_No
      • number_participants766
      • notification
      • approval_date23-12-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-21 10:13:53
      • created2019-11-13 12:12:39
      • total_sites(null)
      • ecitizen_invoice362878
    • InvestigatorContact(array)
      • 0(array)
        • id515
        • application_id833
        • given_nameLoice
        • middle_name
        • family_nameAchieng
        • qualificationMBChB, MMED Internal Medicine, MSC Infectious diseases
        • professional_addressP.O Box 2304-00202, Nairobi
        • telephone+254722576984
        • emailloisea@uonbi.ac.ke
        • created2019-11-13 12:22:32
        • modified2020-06-08 13:05:19
    • SiteDetail(array)
      • 0(array)
        • id674
        • application_id833
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressNgong road
        • contact_detailsP.O Box 19676-00202
        • contact_personDr. Loice Achieng
        • site_capacity(null)
        • misc(null)
        • created2019-11-13 12:22:32
        • modified2020-06-08 13:05:19
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id675
        • application_id833
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressKisumu
        • contact_detailsP.O Box 849-40100
        • contact_personDr. Florentius Ndinya
        • site_capacity(null)
        • misc(null)
        • created2019-11-13 12:22:32
        • modified2020-06-08 13:05:19
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id676
        • application_id833
        • county_id22
        • site_nameThika Level 5 Hospital
        • physical_addressThika Town
        • contact_details0722842741
        • contact_personDr. Jared Mecha
        • site_capacity(null)
        • misc(null)
        • created2019-11-13 12:39:29
        • modified2020-06-08 13:05:19
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 3(array)
        • id677
        • application_id833
        • county_id22
        • site_nameKiambu Level 5 Hospital
        • physical_addressKiambu Town
        • contact_details0722842741
        • contact_personDr. Jared Mecha
        • site_capacity(null)
        • misc(null)
        • created2019-11-13 12:39:29
        • modified2020-06-08 13:05:19
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
    • Sponsor(array)
      • 0(array)
        • id403
        • application_id833
        • sponsorUniversity of Nairobi
        • sponsor_typeOthers
        • contact_personProf. T. M Munyao, Chair, Department of Clinical Medicine and Therapeutics
        • addressP.O Box 19676-00202, Nairobi
        • telephone_number020 4915041
        • fax_number
        • cell_number+254 718703330
        • email_addresstitus.munyao@uonbi.ac.ke
        • created2019-11-13 12:22:32
        • modified2020-06-08 13:05:19
  • 3(array)
    • Application(array)
      • id1424
      • user_id693
      • trial_status_id(null)
      • abstract_of_study<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <strong>BACKGROUND</strong></div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Chronic Obstructive Pulmonary Disease (COPD) was the third leading cause of death worldwide in 2019, accounting for approximately 6% of all deaths. Chronic obstructive pulmonary disease is distinguished by persistent respiratory symptoms and restricted airflow due to airway and/or alveolar abnormalities. COPD exacerbation, defined as an acute worsening of respiratory symptoms requiring additional therapy, is one of the key indicators of disease activity. Chronic obstructive pulmonary disease exacerbations represent the largest burden in terms of healthcare utilization, patient morbidity, and risk of mortality. Current COPD treatment options include non-pharmacologic and pharmacologic measures, which are insufficient to prevent symptoms or slow disease progression. Other safe and efficacious treatment modalities are desperately needed.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <strong>STUDY RATIONALE</strong></div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab, a human IgG2 mAb that selectively inhibits the interleukin-33 (IL-33) receptor ST2, in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in Phase III (GB44332) astegolimab study. The open-label design will allow assessment of the impact of longer treatment duration of astegolimab on safety, lung function, COPD exacerbations, and patient-reported outcomes (PROs).</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <strong>OBJECTIVES AND ENDPOINTS</strong></div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Primary Objective:</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n To evaluate the long-term safety of astegolimab</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Corresponding Endpoint:</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Incidence and severity of adverse events, with severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <strong>OVERALL DESIGN AND STUDY POPULATION</strong></div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n This is a Phase III multicenter, single group open-label extension (OLE) study to evaluate the long-term safety and explore the efficacy of astegolimab (RO7187807) in combination with standard of care (SOC). The study population will be adults aged 40-90 years (at time of consent in parent study), with Chronic obstructive pulmonary disease (COPD). Approximately 2,000 participants with COPD are expected to be enrolled globally, with the Mtwapa site targeting minimum of five patients with COPD who have completed the 52-week treatment period in Study GB44332 and fulfill the eligibility criteria for the OLE, for enrolment.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Patients who have discontinued treatment in the parent study will not be eligible to enroll into the OLE.</div>\n
      • study_title<p style=\"margin: 0px 0px 10px;\">\n A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE</p>\n<div>\n  </div>\n
      • laymans_summary<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that mostly affects older people who have smoked cigarettes in the past or have been exposed to or breathed in other harmful particles for a long time, like smoke from biomass fuels. It is the third leading cause of death worldwide, and the number of people who have it is growing around the world. Even though smoking cigarettes has always been the biggest risk factor for COPD, there is clear evidence that non-smokers can also get the disease.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The risk of COPD goes up with age, and most people with COPD are 40 years old or older. Men are more likely to have COPD than women. COPD is a disease that affects different people in different ways and gets worse over time. The progression of the disease is strongly linked to thickening and narrowing of the airway walls, reducing the lungs' ability to stretch and reducing airflow. Patients withn COPD will present with some of the following signs and symptoms; Cough, shortness of breath and production of a thick mixture of saliva and mucus (sputum) coughed from the airways.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n As symptoms worsen and the disease progresses, the likelihood of death increases. Current existing treatments have been unable to significantly slow down the progression of the disease and prevent episodes of worsened symptoms. New, more effective ways to treat patients that will relieve their symptoms and change the course of the disease are urgently needed.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Astegolimab is a drug that is under investigation for the treatment of patients with COPD. It has been noted to potentially prevent the worsening of symptoms and improve lung function and quality of life for the respective patient populations. This study will look at the long term safety and how well astegolimab works in people with COPD who have used the drug for 1 year in a previous study.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n If found to be safe and efficacious, astegolimab will be recommended for market registration to make it commercially available locally so that people with COPD can have access to the drug in the market, subject to approval by relevant health authorities.</div>\n
      • short_titleALNASA
      • protocol_noECCT/24/06/04
      • version_no2
      • date_of_protocol03-04-2023
      • study_drugAstegolimab (RO7187807)_Dr Mirera
      • disease_conditionChronic Obstructive Pulmonary Disease (COPD)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameAstegolimab (RO7187807) _Dr Mirera
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPhoebe Mercy Otieno
      • declaration_date124-06-2024
      • declaration_principal_investigatorDr. Mirera
      • declaration_date224-06-2024
      • placebo_presentNo
      • study_objectives<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the long-term safety of astegolimab</li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Exploratory Objectives</strong></p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the efficacy of astegolimab</li>\n <li style=\"line-height: 20px;\">\n To evaluate health status utility scores of participants treated with astegolimab</li>\n <li style=\"line-height: 20px;\">\n To evaluate the long-term safety of astegolimab</li>\n <li style=\"line-height: 20px;\">\n To characterize the PK profile of astegolimab</li>\n <li style=\"line-height: 20px;\">\n To evaluate the immune response to astegolimab</li>\n <li style=\"line-height: 20px;\">\n To identify and/or evaluate biomarkers that are predictive of response to astegolimab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), can provide evidence of astegolimab activity (i.e., PD biomarkers), or can increase the knowledge and understanding of disease biology and drug safety or pharmacokinetics</li>\n</ul>\n
      • principal_inclusion_criteria<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Signed Informed Consent Form.</li>\n <li style=\"line-height: 20px;\">\n Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment.</li>\n <li style=\"line-height: 20px;\">\n Completion of the 52-week treatment period in either Study GB43311 or Study GB44332. For patients in Study GB43311 eligible for the additional treatment period: Continued participation in the additional treatment period up to local availability of the OLE is required.</li>\n <li style=\"line-height: 20px;\">\n For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached apostmenopausal state (at least12 continuous months of amenorrhea with no identified cause other than menopause),and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mü llerian agenesis). The definition of childbearingpotential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.</li>\n</ul>\n
      • principal_exclusion_criteria<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Withdrawal of consent and/or premature discontinuation from parent study</li>\n <li style=\"line-height: 20px;\">\n Any permanent discontinuation of study drug in parent study</li>\n <li style=\"line-height: 20px;\">\n Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator’s judgment</li>\n <li style=\"line-height: 20px;\">\n Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug.</li>\n <li style=\"line-height: 20px;\">\n Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study</li>\n <li style=\"line-height: 20px;\">\n Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study</li>\n <li style=\"line-height: 20px;\">\n Treatment with a licensed respiratory biologic agent (e.g., omalizumab, dupilumab, and/or anti-IL-5 therapies) at the time of study entry</li>\n <li style=\"line-height: 20px;\">\n Initiation of treatment that is considered palliative (e.g., for life expectancy < 12 months) since enrolling in the parent study</li>\n <li style=\"line-height: 20px;\">\n History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab</li>\n <li style=\"line-height: 20px;\">\n Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study</li>\n <li style=\"line-height: 20px;\">\n Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study</li>\n <li style=\"line-height: 20px;\">\n Any new abnormal ECG that is deemed clinically significant by the investigator, including complete left bundle branch block or second- or third-degree atrioventricular heart block since enrolling in the parent study</li>\n <li style=\"line-height: 20px;\">\n QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF > 480ms</li>\n</ul>\n
      • primary_end_points<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Primary Objective Endpoints</strong></div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Incidence and severity of all adverse events, including SAEs, AESIs and AEs leading to death or discontinuation. Severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (HHS 2017) (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n Clinical Research Health Network (CREA-N) clinical trials unit (CTU) at Machakos Level 5 Hospital is a collaboration between Machakos County Department of Health and Emergency Services & CREA-N based on a memorandum of understanding that was established to support and develop clinical research capacity in response to relevant health research priorities. CREAN has sufficient capacity to support the operationalisation of the protocol:</div>\n<div>\n  </div>\n<div>\n i. Infrastructure: CREA-N has dedicated research facilities at Machakos Level 5</div>\n<div>\n Hospital in compliance with ICH-GCP principles:  </div>\n<div>\n a. Kenya Accredited Service (KENAS) Laboratory  </div>\n<div>\n i. Short-term and long-term sample storage capabilities (-2⁰c & -8⁰C)  </div>\n<div>\n ii. Real-time temperature monitoring of samples and remote alarm system for outof-range</div>\n<div>\n temperatures</div>\n<div>\n iii.Established vendors relationships to support sample testing where the capability is not available internally e.g., Lancet Laboratories.  </div>\n<div>\n b. Pharmacy </div>\n<div>\n i. Cold-chain capabilities for vaccine management  </div>\n<div>\n <div>\n ii. Real-time temperature monitoring of samples and remote alarm system for outof-range</div>\n <div>\n temperatures</div>\n <div>\n c.Research clinic and procedure rooms that can be scaled based on study requirements. </div>\n <div>\n d. Technology: Paperless eSource technology for enhanced investigator(s) oversight </div>\n <div>\n e. Emergency management for study related adverse events. </div>\n <div>\n f. Established external vendors supporting the clinical trials ecosystem for established capabilities ranging from logistics and laboratory services.  </div>\n <div>\n ii. Personnel: All staff participating in the conduct of clinical trials at CREA-N CTU, are trained on the protocol, study specific procedures and are qualified by education for the roles they are engaged in, in compliance with ICH-GCP principles, local and global guidelines governing the conduct of clinical trials. Staffing demands are scaled per study, according to the stage of an ongoing trial and the number of concurrent trials at the research unit.   </div>\n <div>\n a. Dedicated research staff: CREA-N maintains a team of dedicated clinical trials staff to ensure consistency and quality across all studies. The staff ensure adequate training, conduct, management and evaluation of projects and teams. Dedicated staff represent the medical, nursing, pharmacy, laboratory, data management, community engagement, study coordination and technology departments.    </div>\n <div>\n b. Collaborative staff: CREA-N is embedded in the Machakos County health delivery system and based on the collaborative agreement between CREA-N and Machakos County Department of Health and Emergency Services. Multidisciplinary teams from the health system based on the specific needs of a trial are established per trial for the successful delivery of studies. For example, in collaboration with the permanent CTU staff, the community health workers will proactively drive the community engagement strategy based on the target geographies that the study will recruit from. This team will be scaled as needed during the different phases of the trial.  </div>\n <div>\n  The collaborative partnership between the Machakos County Department of Health and Emergency Services and CREA-N allow for flexible deployment of infrastructure and personnel to support the fluctuating needs of the trial over the next 5 years. We have the following staff engaged for this study Principal Investigator-1, Co-Investigators 3, Medical Officers-1, Study clinicians-2, Pharmacists -2, Study nurses-3, QA/QC officers -2, Laboratory personnel –3 and Community liaison officer-2, Community health volunteers-8. The numbers shall be adjusted based on workload and concurrent trials taking place. </div>\n <div>\n All study staff are qualified by training, education, and experience. They are all registered, certified, and licensed by professional regulatory bodies. These requirements are confirmed during a competitive recruitment by strict human resource criteria. Staff documents are kept by the human resource department and updated annually and as required by ICH-GCP guidelines. </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n  </p>\n<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Switzerland is the host country and we already received approval in Switzerland. CEC and RA approvals were received on 17-Sep-2024</span></p>\n
      • other_details_regulatory_notapproved<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 589px; height: 21px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>  competent Authority                                                                              DATE SUBMITTED</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>INDIA </strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 30-Apr-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Pending</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 589px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>C</strong><strong>HINA</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n To be submitted</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>B</strong><strong>RAZIL</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 16-May-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>P</strong><strong>ERU</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 15-Mar-2024 (first site)</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Pending</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 589px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>List of Competent Authorities inside the EU/EEA to which the Application Approved</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Member State </strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>EU</strong> <strong>CTR</strong></p>\n <p style=\"margin: 0px 0px 10px;\">\n BELGIUM (11 sites), BULGARIA(25 sites), CZECH REPUBLIC (10sites), DENMARK (6sites), FRANCE (7sites), GERMANY (30sites), NETHERLANDS (5 sites), POLAND (36sites) , ROMANIA (4 sites), SPAIN (16sites), SWEDEN (6sites)</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 30-May-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 2-Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>EU</strong> <strong>CTR</strong></p>\n <p style=\"margin: 0px 0px 10px;\">\n GREECE, HUNGARY, ITALY, LATVIA, AUSTRIA</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 25-Jun-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n <p style=\"margin: 0px 0px 10px;\">\n GREECE – Approved, 18-Sep2024</p>\n <p style=\"margin: 0px 0px 10px;\">\n HUNGARY - Approved, 03-Sep2024</p>\n <p style=\"margin: 0px 0px 10px;\">\n ITALY - Approved, 16-Sep2024</p>\n <p style=\"margin: 0px 0px 10px;\">\n LATVIA - Approved, 17-Sep2024</p>\n <p style=\"margin: 0px 0px 10px;\">\n AUSTRIA - Approved, 22Sep2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>List of Competent Authorities outside the EU/EEA to which the Application has been approved</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Country</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>UNITED KINGDOM (17sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 25-May-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 31-Aug2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>ARGENTINA (40sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 22-Jun-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 11-Sep-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>AUSTRALIA (4 sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 02-Jun-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 15-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 19px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>CHILE (10sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 19px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 18-Oct-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 20-Dec2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 19px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>HONG KONG (1 site)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 19px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 24-Aug-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 21-Nov2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 21px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>MEXICO (4 sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 21px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 21px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 28-Jul-2023 </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 6-Nov-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>CANADA (14sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 24-May-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 23-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>NEW ZEALAND (7sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 14-Jun-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 7-Jul2023</p>\n <div>\n  </div>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Country</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>SOUTH AFRICA (15sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 30-May-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved,12-Sep2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>SOUTH KOREA (13sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 9-Jun-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 10Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>UNITED STATES OF AMERICA (74sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 13-Feb-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 589px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>TAIWAN (6sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 29-Mar-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved,28-May2024</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 589px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>TURKEY (3sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 20-Mar-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved，9 Aug2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>S</strong><strong>WITZERLAND (1site)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 29-Jul-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved,16-Sep2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>T</strong><strong>HAILAND (2 sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 21-May-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <strong>Philippines</strong></td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n 18Apr2024</td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n 23Sep2024</td>\n </tr>\n </tbody>\n</table>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<div>\n  </div>\n
      • other_details_regulatory_rejected<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Not applicable. None of the Regulatory Authorities or Ethics Committees have rejected this trial.</p>\n
      • other_details_regulatory_halted<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Not applicable. </span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n
      • estimated_durationStudy participation for each individual is expected to range from 1 day to more than 51 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states34
      • number_of_sites5
      • multi_country_listBelgium, Bulgaria, Czech Republic, Denmark, France, Germany, Netherlands, Poland, Romania, Spain, Sweden, United Kingdom, Argentina, Australia, Chile, Hong Kong, Mexico, Canada, Israel, New Zealand, Peru, South Africa, South Korea, United States of America, Switzerland, Taiwan, Thailand, Turkey, India, China, Brazil, Kenya, Vietnam, Phillipine
      • data_monitoring_committeeYes
      • total_enrolment_per_siteApproximately 4 participants for this site.
      • total_participants_worldwideApproximately 2000 participants
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
      • investigator1_telephone+254790484654
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsApproximately 18 participants
      • notification
      • approval_date23-10-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-06-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted25-06-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-30 11:20:46
      • created2024-06-22 12:57:10
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1081
        • application_id1424
        • given_nameJacqueline
        • middle_name
        • family_nameMirera
        • qualificationMedica Doctor
        • professional_addressP.O.Box 19 - 90100
        • telephone+254 115021107
        • emailjacquline.mirera@crean-health.com
        • created2024-06-22 13:11:53
        • modified2024-11-18 13:48:23
    • SiteDetail(array)
      • 0(array)
        • id1729
        • application_id1424
        • county_id16
        • site_nameClinical Research Health Network (CREA-N)
        • physical_addressMachakos Level 5 Hospital Site P.O. Box 19 -90100 Machakos Kenya
        • contact_details+254115021107
        • contact_personDr Jacqueline Mirera
        • site_capacity(null)
        • misc(null)
        • created2024-06-22 13:11:53
        • modified2024-11-18 13:48:23
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
    • Sponsor(array)
      • 0(array)
        • id757
        • application_id1424
        • sponsorF. Hoffmann-La Roche Ltd
        • sponsor_typeIndustry
        • contact_personHeather Schofield
        • addressGrenzacherstrasse 124, 4070 Basel, Switzerland
        • telephone_number+41 6168 81111
        • fax_number
        • cell_number+41 61 688 1111
        • email_addressglobal.eudract@roche.com
        • created2024-06-22 13:11:53
        • modified2024-11-18 13:48:23
  • 4(array)
    • Application(array)
      • id157
      • user_id84
      • trial_status_id(null)
      • abstract_of_study<p style=\"margin: 0px 0px 10px;\">\n <strong style=\"color: rgb(51, 51, 51); font-family: \'Helvetica Neue\', Helvetica, Arial, sans-serif; font-size: 14px; line-height: 20px;\">HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high-risk for HIV-acquisition. The majority of HIV-1 transmissions to adults in Africa occur within stable, HIV-1 discordant couples. Novel strategies to prevent HIV-1 transmission within discordant couples, especially interventions that might allow pregnancy to occur safely, are urgently needed. Pre-exposure chemoprophylaxis, in which an HIV-1 uninfected individual at high risk for contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been proposed as a potential HIV-1 prevention strategy. A randomized, blinded, placebo-controlled trial is required to demonstrate if PrEP decreases HIV-1 acquisition and has an acceptable safety profile when given to HIV-1 uninfected individuals within HIV-1 discordant partnerships.</strong></p>\n<p style=\"margin: 0px 0px 10px;\">\n <strong style=\"color: rgb(51, 51, 51); font-family: \'Helvetica Neue\', Helvetica, Arial, sans-serif; font-size: 14px; line-height: 20px;\">Both tenofovir disoproxil fumarate (TDF) and co-formulated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) have been proposed as possible safe and effective medications to serve as pre-exposure chemoprophylaxis. The potential for differential safety, cost, and efficacy for these two medications justifies evaluating both, against placebo, in a single clinical trial. This trial will directly answer whether PrEP decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples, a very high-risk heterosexual population who could benefit from this type of intervention, if found to be safe and efficacious.</strong></p>\n
      • study_title<p style=\"margin: 0px 0px 10px;\">\n <strong style=\"color: rgb(51, 51, 51); font-family: \'Helvetica Neue\', Helvetica, Arial, sans-serif; font-size: 14px; line-height: 20px;\">Parallel Comparison of Tenofovir and Emtricitabine/tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples</strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/08/08/02
      • version_no3.0
      • date_of_protocol12-10-2007
      • study_drugTenofovir, Tenofovir/emtricitabine
      • disease_conditionHIV-1
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameViread, Truvada
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspipscoordinatoreldoret@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantProf. Edwin Were
      • declaration_date115-07-2013
      • declaration_principal_investigatorDr. Nelly Mugo
      • declaration_date215-07-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <strong><u>Inclusion Criteria for Potential HIV-1 uninfected (Partner) participants:  </u></strong></p>\n<p>\n •  Of legal age to provide independent informed consent for research per local regulations and guidelines</p>\n<p>\n • Age ≥18 and ≤65 </p>\n<p>\n •  Able and willing to provide written informed consent to be screened for and to take part in the study</p>\n<p>\n •  HIV-1 uninfected based on parallel negative HIV-1 rapid tests, both at study screening and at the enrollment visit </p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Adequate renal function, defined by creatinine clearance ≥ 60ml/min estimated by the Cockcroft Creatinine Clearance Formula AND serum creatinine level of ≤ 1.3 mg/dL for men / ≤1.1 mg/dL for women, measured within 56 days of enrollment</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Adequate hepatic function, defined by total bilirubin ≤1.5x upper limit of normal AND hepatic transaminases (ALT and AST) <2x upper limit of normal, measured within 56 days of enrollment</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Adequate hematologic function, defined by absolute neutrophil count >1,300/mm³, platelets >125,000/mm³, and hemoglobin >11 g/dL, measured within 56 days of enrollment</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Not infected with HBV, as determined by a negative hepatitis B surface antigen test, further defined in Appendix VI</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Part of a heterosexual couple in which one partner meets the study eligibility criteria for index (HIV-1 infected) participants and the other partner meets the study eligibility criteria for partner (HIV-1 uninfected) participants, including the following  criteria for the couple:</p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:.75in;\">\n •  are partners who are sexually active (defined as having had vaginal intercourse with the partner [HIV-1 uninfected] participant at least 6 times in the last three months) </p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:.75in;\">\n •  plan to remain in the relationship for the duration of the study period.</p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p style=\"margin-left:.75in;\">\n  </p>\n<p>\n <strong><u>Inclusion Criteria for Potential HIV-1 infected (Index) participants:  </u></strong></p>\n<p>\n •  Of legal age to provide independent informed consent for research per local regulations and guidelines. </p>\n<p>\n  </p>\n<p>\n •  Able and willing to provide written informed consent to be screened for and to take part in the study.</p>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p>\n •  Part of a heterosexual couple in which one partner meets the study eligibility criteria for index (HIV-1 infected) participants and the other partner meets the study eligibility criteria for partner (HIV-1 uninfected) participants.   </p>\n<p>\n  </p>\n<p>\n •  HIV-1 infected based on positive EIA. </p>\n<p>\n  </p>\n<p>\n •  CD4 cell count ≥250 cells/mm³ and not otherwise meeting national guidelines for initiation of antiretroviral therapy. </p>\n<p>\n  </p>\n<p>\n •  No history of any clinical AIDS-defining diagnoses.</p>\n<p>\n  </p>\n<p>\n •  Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong><u>Exclusion Criteria for Potential HIV-1 uninfected (Partner) participants:  </u></strong></p>\n<p>\n •  Current pregnancy, or planning to become pregnant during the study period</p>\n<p>\n  </p>\n<p>\n • Current breastfeeding</p>\n<p>\n •  Must not be currently enrolled in another HIV-1 vaccine or prevention trial.</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period.</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Repeated positive (≥1+) urine dipstick tests for glycosuria or  proteinuria. Participants with definite evidence of glucose and/or protein in their urine will not be eligible.  If a urine dipstick is positive for either glucose and/or protein at the first screening visit, a second urine sample will be tested. </p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Active and serious infections, including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy; active clinically significant medical problems including cardiac disease (e.g., symptoms of ischemia, congestive heart failure or arrhythmia), pulmonary disease (steroid dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication; and previously diagnosed malignancy expected to require further treatment.</p>\n<p style=\"margin-left:182.65pt;\">\n  </p>\n<p>\n •  History of pathological bone fractures not related to trauma</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Receiving ongoing therapy with any of the following: antiretroviral therapy (ART), including nucleoside analogs, nonnucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy,  metformin, aminoglycoside antibiotics, amphotericin B, cidofovir, systemic chemotherapeutic agents, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives (including, for couples previously enrolled in the Partners in Prevention HSV/HIV Transmission Trial, having more than 2 missed visits or more than 2 visits outside the visit window)</p>\n<p>\n  </p>\n<p>\n <strong><u>Exclusion Criteria for Potential HIV-1 infected (Index) participants:  </u></strong></p>\n<p>\n •  Current use of antiretroviral therapy</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  Currently enrolled in another HIV-1 treatment trial</p>\n<p style=\"margin-left:164.65pt;\">\n  </p>\n<p>\n •  At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives (including, for couples previously enrolled in the Partners in Prevention HSV/HIV Transmission Trial, having more than 2missed visits or more than 2 visits outside the visit window)</p>\n<p style=\"margin-left:182.65pt;\">\n  </p>\n
      • primary_end_points<p style=\"margin-left:56.65pt;\">\n Incident HIV-1 infection will be the primary study endpoint and will be defined as</p>\n<p style=\"margin-left:56.65pt;\">\n i) serologically confirmed incident HIV-1 <span style=\"font-size: 12px;\">infection, with the exception that the enrollment sample from any partner (HIV-1 </span><span style=\"font-size: 12px;\">uninfected) participant who is serologically positive at a visit within the first three months </span><span style=\"font-size: 12px;\">after enrollment will be tested for HIV-1 RNA by PCR.  Detectable HIV-1 RNA at </span><span style=\"font-size: 12px;\">enrollment will indicate infection prior to randomization and this individual will be </span><span style=\"font-size: 12px;\">excluded from efficacy analyses; </span></p>\n<p style=\"margin-left:56.65pt;\">\n <span style=\"font-size: 12px;\">ii)  HIV-1 RNA >50 copies/ml by PCR at the last study </span><span style=\"font-size: 12px;\">visit of any subject – in particular, individuals who are RNA positive at Stop Visit who </span><span style=\"font-size: 12px;\">then seroconvert at the post-study drug visit; iii) other incident HIV-1 infections as </span><span style=\"font-size: 12px;\">determined and documented by the endpoint review committee (see below).  Sequence </span><span style=\"font-size: 12px;\">matching of index (HIV-1 infected) and seroconverting partner HIV-1 viral clones will be </span><span style=\"font-size: 12px;\">performed for the purpose of facilitating the secondary study objective of evaluating the </span><span style=\"font-size: 12px;\">impact of index (HIV-1 infected) participant factors (e.g., HIV-1 plasma viral load) on </span><span style=\"font-size: 12px;\">PrEP efficacy.  </span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table align=\"center\" border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"727\">\n <tbody>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>NAME</em></strong></p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>TITLE/ROLE</em></strong></p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>QUALIFICATION</em></strong></p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>STUDY START DATE</em></strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 1. Prof. Edwin Were</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Site Principal Investigator</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n MBChB, MMed, MPH</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 2. Prof. Ken Fife</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Principal Investigator (Indiana)</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n MD, PhD</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 3. Prof. Paul Ayuo</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Co-PI, Clinical Consultant</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n MBChB, MMed, MSc</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 4. Dr. Dismas Oketch</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Site Coordinator</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n MBChB, MSc</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Nov 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 5. Jairus K Cheruiyot</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Study Clinical Officer</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n Dip Clinical Medicine</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 6. Jacinta Sawe</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Community Health Educator</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KRCHN, BSc</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Nov 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 7. Nereo Murgor</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Lead Nurse Counselor</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n BSN</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Nov 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;height:5px;\">\n <p align=\"left\">\n 8. Eunice Kaguiri</p>\n </td>\n <td style=\"width:236px;height:5px;\">\n <p align=\"left\">\n Senior Data Manager</p>\n </td>\n <td style=\"width:147px;height:5px;\">\n <p align=\"left\">\n BSc, MPH</p>\n </td>\n <td style=\"width:144px;height:5px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 9. Wilfred Emonyi</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Lab Manager (AMPATH)</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n PhD</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;height:5px;\">\n <p align=\"left\">\n 10. Juda Kimuge</p>\n </td>\n <td style=\"width:236px;height:5px;\">\n <p align=\"left\">\n Study Laboratory Technologist</p>\n </td>\n <td style=\"width:147px;height:5px;\">\n <p align=\"left\">\n BSc</p>\n </td>\n <td style=\"width:144px;height:5px;\">\n <p align=\"left\">\n Non 2008</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;height:5px;\">\n <p align=\"left\">\n 11. Ogola C. Achieng</p>\n </td>\n <td style=\"width:236px;height:5px;\">\n <p align=\"left\">\n Phlebotomist, Lab Assistant</p>\n </td>\n <td style=\"width:147px;height:5px;\">\n <p align=\"left\">\n Cert. Phlebotomy</p>\n </td>\n <td style=\"width:144px;height:5px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;height:5px;\">\n <p align=\"left\">\n 12. Alicen Jepkemei Komen</p>\n </td>\n <td style=\"width:236px;height:5px;\">\n <p align=\"left\">\n Lead Pharmacy Technologist</p>\n </td>\n <td style=\"width:147px;height:5px;\">\n <p align=\"left\">\n Dip Pharmacy</p>\n </td>\n <td style=\"width:144px;height:5px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 13. Francis M. Mudogo</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Accountant/Administrator</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KATC, CPA</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 14. Mbinda Ellionorah</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Study Secretary/receptionist</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KNEC</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 15. Kutwa Godfrey</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n CHCT Counselor</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n CHCT Counselor</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 16. Christine Kapere</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n CHCT Counselor</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n CHCT Counselor</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 17. Gatetua Mungai</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n VCT Liaison</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KRCHN</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 18. Joyce B. Baliddawa</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Behavioral Consultant</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n PhD</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 19. Stella Kerubo</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Office Asst</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n KIPC</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n May 2008</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n 20. Charles Odhiambo</p>\n </td>\n <td style=\"width:236px;\">\n <p align=\"left\">\n Driver/Outreach Worker</p>\n </td>\n <td style=\"width:147px;\">\n <p align=\"left\">\n Dip Marketing</p>\n </td>\n <td style=\"width:144px;\">\n <p align=\"left\">\n Sept 2007</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"4\" style=\"width:727px;\">\n <p align=\"left\">\n  </p>\n <p align=\"left\">\n <strong><em>SITE FACILITIES, EQUIPMENT & OTHER RESOURCES</em></strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Site IEC/IRB</p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n Moi University/Moi Teaching and Referral Hospital, Institutional Research and Ethics Committee (MU/MTRH IREC). IREC has been mandated to review and approve protocols on behalf of the National Council of Science and Technology (the national regulatory authority). IREC has a Federal wide Assurance No. FWA 00003128. IREC is composed of 17 members (representing the Schools of Medicine, Nursing, Dentistry, Public Health and the Teaching and Referral Hospital and the community) that meet monthly to review protocols. </p>\n <p align=\"left\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Study facility &Equipment</p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n The site is located at the Partners House along Nandi Road. It comprises 18 rooms: The Coordinator’s Office, the Accountant/Administrator’s Office, 1 Data Room, 1 Outreach Office, 1 Staff Room, 1 Pharmacy Room., 4 Counselling/Consenting Rooms, 4 Self-contained Clinical/Examination Rooms, 1 Store, 1 training/Conference Room, 1 Archive and a Reception/Waiting Area. The facility is equipped with reliable internet & telephone connection; desktop & laptop computers; printers; photocopiers, data fax machines, filing cabinets & vehicles. All equipments are maintained and calibrated accordingly</p>\n <p align=\"left\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Site Laboratory</p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n The site incorporates the AMPATH Reference Laboratory providing access to all required facilities for this study, specifically: three -80C and four -20C freezers and multiple centrifuges.  The laboratory is staffed by appropriately trained personnel ensuring that IATA regulations for the shipping of biological samples are adhered to.  A Quality Control system is in place that ensures all procedures are performed according to GCLP & GLP standards. The lab is accredited by KENAS and awarded ISO 15189:2007 Accreditation. The laboratory provides services to the AMPATH program and all clinical trials under Moi University College of Health Sciences.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Site Pharmacy</p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n There is a study pharmacy ensuring that all study medications can be stored, dispensed and returned in accordance with study requirements; for this study, product will be stored in an access-controlled environment and maintained at a temperature between 15-30^oC .</p>\n <p align=\"left\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Consulting Rooms</p>\n <p align=\"left\">\n  </p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n The site is set-up to ensure private consulting rooms ensuring confidentiality when consenting and during subject visits.  Separate counseling rooms are available, if required. </p>\n <p align=\"left\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:198px;\">\n <p align=\"left\">\n Emergency Facilities</p>\n <p align=\"left\">\n  </p>\n </td>\n <td colspan=\"3\" style=\"width:527px;\">\n <p align=\"left\">\n A comprehensive emergency service (Moi Teaching & Referral Hospital) is accessible within minutes. The hospital has an inpatient bed capacity of 800 and admits 27,741 adults and 9545 children annually. The hospital has close to 200 doctors specialized in various fields of medicine, pediatrics, obstetrics and gynecology, surgery, psychiatry, critical care and medical research.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<div style=\"clear:both;\">\n  </div>\n
      • other_details_explanation<p style=\"margin-left:56.65pt;\">\n The HIV-1 pandemic continues to have the greatest impact in sub-Saharan Africa, where 25 million of the estimated 40 million adults and children living with HIV/AIDS worldwide reside. Before undertaking the Partners PrEP Study, the University of Washington’s International Clinical Research Center has previously sponsored another HIV-1 prevention study among HIV Discordant couples across 11 countries in Sub-Saharan Africa between 2004 and 2008 [the HSV-2/HIV-1 Acyclovir Study].</p>\n<p style=\"margin-left:56.65pt;\">\n It has been reported that Kenya and Uganda were chosen because of advanced or well organinsed [HIV] research infrastructure and fairly better described epidemiological data.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p style=\"margin-left:92.65pt;\">\n ·         University of Washington, Human Subjects Division, formal approval  dated 1^st October 2007</p>\n<p style=\"margin-left:92.65pt;\">\n ·         Indiana University-Perdue University Indianapolis, IRB formal approval dated 11^th January 2008</p>\n<p style=\"margin-left:92.65pt;\">\n ·         Moi University Moi Teaching and Referral Hospital IREC formal approval dated 5^th March, 2008</p>\n<p style=\"margin-left:92.65pt;\">\n ·         Pharmacy and Poisons Board formal approval dated 25^th August, 2008</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specify3-arm study
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites4
      • multi_country_listKenya, Uganda
      • data_monitoring_committeeYes
      • total_enrolment_per_siteEldoret site (976 participants), Thika site (496), Nairobi site (485) and Kisumu site (629 participants)
      • total_participants_worldwide9, 516
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNelly
      • investigator1_middle_nameRwamba
      • investigator1_family_nameMugo
      • investigator1_qualificationMBChB, MMed (O/G), MPH
      • investigator1_professional_addressKenyatta National Hospital, UNITID Building, 3rd Floor, Room 302
      • investigator1_telephone254 733 629 665
      • investigator1_emailrwamba@csrtkenya.org
      • organisations_transferred_No
      • number_participants4000 - 6400
      • notification<p>\n We thank the PPB particularly the ECCT for the continuing guidnace and support the conduct of relevant and impactful clinical reaearch in Kenya</p>\n
      • approval_date25-07-2008
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-07-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2013-08-05 09:56:30
      • created2013-06-25 13:56:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id100
        • application_id157
        • given_nameEdwin
        • middle_nameOnyango
        • family_nameWere
        • qualificationAssociate Professor of Reproductive Health: MBChB, MMed (O/G), MPH
        • professional_addressMoi University School of Medicine, Department of Reproductive Health,P.O. Box 4606, Eldoret
        • telephone+254 733 759 942
        • emaileowere@gmail.com
        • created2013-06-25 15:14:51
        • modified2013-07-17 09:41:45
    • SiteDetail(array)
      • 0(array)
        • id127
        • application_id157
        • county_id27
        • site_nameEldoret Site
        • physical_addressMoi University, School of Medicine, Partners in Prevention, Partners House, Nandi Road
        • contact_detailsP.O. Box 4606. Eldoret; Tel +254 734 256 186, +254 720 473 785
        • contact_personDr. Dismas Oketch
        • site_capacity(null)
        • misc(null)
        • created2013-06-25 15:14:51
        • modified2013-07-17 09:41:45
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 1(array)
        • id137
        • application_id157
        • county_id42
        • site_nameKisumu Site
        • physical_addressCIS Project, KEMRI-UCSF Building, Lumumba Health Center, Agoi Street
        • contact_detailsP.O. Box 614, Kisumu; Tel +254 733276 275
        • contact_personJosephine Odoyo
        • site_capacity(null)
        • misc(null)
        • created2013-07-11 13:54:57
        • modified2013-07-17 09:41:45
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id138
        • application_id157
        • county_id22
        • site_nameThika Site
        • physical_addressThika Partners in Prevention House, next to Thika Nursing Home, Section 9
        • contact_details+254 6722561
        • contact_personDr. Kenneth Ngure
        • site_capacity(null)
        • misc(null)
        • created2013-07-11 13:54:57
        • modified2013-07-17 09:41:45
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 3(array)
        • id139
        • application_id157
        • county_id47
        • site_nameNairobi Site
        • physical_addressKenyatta National Hospital, Couples Counselling Center
        • contact_details+254 202 344 344
        • contact_personCarol Ndungu
        • site_capacity(null)
        • misc(null)
        • created2013-07-11 13:54:57
        • modified2013-07-17 09:41:45
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id81
        • application_id157
        • sponsorUniversity of Washington, International Clinical Research Center
        • sponsor_type(null)
        • contact_personConnie Celum
        • addressBox 359927, 325 Ninth Avenue, Seattle, WA 98104 USA
        • telephone_number206 520 3825
        • fax_number206 520 3831
        • cell_number206 915 8972
        • email_addressccelum@u.washington.edu
        • created2013-06-25 15:14:51
        • modified2013-07-17 09:41:45
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php