Request History

• Restore to current request
• applications/index/page:99/sort:protocol_no/direction:desc/approved:1
• applications/index/page:94/approved:2/sort:study_title/direction:asc
• applications/index/page:95/approved:2
• applications/index/page:91/approved:2/sort:study_title/direction:asc

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1746264074
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • page97
  • approved2
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page97
    • current5
    • count502
    • prevPage(true)
    • nextPage(true)
    • pageCount101
    • order(array)
      • Application.createddesc
    • limit5
    • options(array)
      • page97
    • 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  • 9Application withdrawn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)
      • id96
      • user_id68
      • trial_status_id1
      • abstract_of_study<p>\n This international study is a prospective non-interventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.</p>\n
      • study_title<p>\n XANTUS EMEA-LA. Xarelto® on prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A non-interventional study</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/04/02
      • version_noXA1206
      • date_of_protocol06-12-2012
      • study_drugRivaroxaban/ BAY 59-7939
      • disease_conditionPrevention of stroke and non-CNS systemic embolism in adult patients with non-valvular atrial fibrillation
      • 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_nameRivaroxaban
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressElizabeth.Wala@bayer.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_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_applicantDr Elizabeth Wala
      • declaration_date112-04-2013
      • declaration_principal_investigatorDr Charles Kariuki
      • declaration_date212-04-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study. All contra-indications according to the local marketing authorization should be considered.</p>\n
      • principal_exclusion_criteria<p>\n <18years</p>\n<p>\n refusing consent</p>\n<p>\n not having non-valvular Atrial Fibrillation</p>\n
      • primary_end_points<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:437px;height:33px;\">\n <p>\n ï‚· Major bleeding events, collected as serious or no serious adverse events and defined as overt bleeding associated with:</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:437px;height:31px;\">\n <p>\n o a fall in haemoglobin of ≥2 g/dL, or o a transfusion of ≥2 units of packed red blood cells or whole blood, or</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:437px;height:39px;\">\n <p>\n o occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or o death.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:437px;height:10px;\">\n <p>\n ï‚· Adverse events and serious adverse events</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:437px;height:33px;\">\n <p>\n ï‚· All-cause mortality Major bleeding events, stroke, TIA systemic embolism, myocardial infarction will be adjudicated.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\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_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<p>\n Study co-ordinator: Dr Redempter Kimeu</p>\n<p>\n 5 Physician/Cardiologists</p>\n<p>\n 10 nurses</p>\n<p>\n Adequate site facility</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n For the following countries:</p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"96\">\n <colgroup>\n <col />\n </colgroup>\n <tbody>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;width:96px;\">\n Algeria</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Belarus</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Kenya</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Egypt</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Jordan</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Kazakhstan</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n KSA</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Kuwait</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Lebanon</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Morocco</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Qatar</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Russia</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Tunisia</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n UAE</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Ukraine</td>\n </tr>\n <tr height=\"40\">\n <td height=\"40\" style=\"height:40px;width:96px;\">\n  </td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;\">\n Argentina</td>\n </tr>\n <tr height=\"19\">\n <td height=\"19\" style=\"height:19px;\">\n Chile</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Colombia</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Ecuador</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Mexico</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Peru</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Venezuela</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n European Medicines Authority (EMA) for the whole protocol in the EU countries. 12th March 2012</p>\n
      • other_details_regulatory_rejected<p>\n N/AN</p>\n
      • other_details_regulatory_halted<p>\n N/A</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_areaNairobi Cardiovascular Clinic
      • single_site_physical_address(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states22
      • number_of_sites
      • multi_country_listAlgeria\nBelarus\nKenya\nEgypt\nJordan\nKazakhstan\nKSA\nKuwait\nLebanon\nMorocco\nQatar\nRussia\nTunisia\nUAE\nUkraine\nArgentina\nChile\nColombia\nEcuador\nMexico\nPeru\nVenezuela\n
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide2000
      • 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_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_nameDr Redempter
      • investigator1_middle_name
      • investigator1_family_nameKimeu
      • investigator1_qualificationPhysician
      • investigator1_professional_addressNairobi Cardiovascular Clinic
      • investigator1_telephone(null)
      • investigator1_email(null)
      • organisations_transferred_Yes
      • number_participants100
      • notification<p>\n This is a Phase IV study hence many things of Phase 1 to 3 clinical trials do not apply e.g. Investigational Product GMP, patient insurance etc.</p>\n
      • approval_date06-03-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-04-2013
      • 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)
      • modified2014-02-20 16:43:27
      • created2013-04-11 14:09:38
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id66
        • application_id96
        • given_nameDr Charles
        • middle_nameMuthui
        • family_nameKariuki
        • qualificationInterventional Cardiologist
        • professional_addressThe Nairobi Hospital
        • telephone(null)
        • email(null)
        • created2013-04-12 22:05:41
        • modified2013-04-12 22:49:59
    • SiteDetail(array)
      • 0(array)
        • id88
        • application_id96
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-04-12 22:05:41
        • modified2013-04-12 22:49:59
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id51
        • application_id96
        • sponsorBayer HealthCare AG, Germany
        • sponsor_type(null)
        • contact_personDr Wala Elizabeth
        • addressP.O. Box 30321 - 00100 Nairobi, Kenya
        • telephone_number+254 20 8600 403
        • fax_number+254 20 8600 010
        • cell_number+254 722 775932
        • email_addressElizabeth.Wala@bayer.com
        • created2013-04-12 22:05:41
        • modified2013-04-12 22:49:59
  • 1(array)
    • Application(array)
      • id93
      • user_id21
      • trial_status_id5
      • abstract_of_study<p style=\"margin-left: 40px;\">\n <u>DESIGN</u>                      A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to non-nucleoside reverse transcriptase (nNRTI)-based ART for clearance of <em>Plasmodium falciparum (Pf)</em> subclinical parasitemia (SCP). </p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n Participants will be followed for 30 days in order to evaluate parasitemia clearance, <em>Pf</em> parasitemia, gametocytemia, and plasmepsin sequencing.  Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and three times for day 15 and day 30. Therefore, on most study days, participants will need to either remain at the clinic for an extended period of time or be willing to return two or three times at approximately 8-hour intervals (see section 6.2 for details).</p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n <u>DURATION</u>                30 days:  Step 1= days 1-15; Step 2= days 16-30</p>\n<p style=\"margin-left: 40px;\">\n                                    </p>\n<p style=\"margin-left: 40px;\">\n <u>SAMPLE SIZE</u>            52 participants</p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n <u>POPULATION</u>            HIV infected adults at least 18 years of age with CD4+ counts >200 and <u><</u> 350 cells/mm³ who will be starting ART and have <em>Pf</em> SCP.  Individuals with signs or symptoms suggestive of concurrent opportunistic infections, pulmonary or gastrointestinal infections, or clinical malaria will be excluded.</p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n <u>REGIMENS</u>                <u>Step 1</u></p>\n<p style=\"margin-left: 40px;\">\n Participants will be randomized 1:1 to one of the following arms for 15 days: </p>\n<p>\n                                     Arm A: LPV/r-based ART</p>\n<p style=\"margin-left: 40px;\">\n Arm B: nNRTI-based ART</p>\n<p style=\"margin-left: 40px;\">\n  </p>\n<p style=\"margin-left: 40px;\">\n <u>Step 2</u></p>\n<p style=\"margin-left: 40px;\">\n All participants will receive an nNRTI-based ART and TMP/SMX prophylaxis to take from day 16 through day 30.</p>\n
      • study_title<p>\n A5297: An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of</p>\n<p>\n <em>Plasmodium falciparum</em> Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and <u><</u>350 cells/mm³</p>\n
      • laymans_summary(null)
      • short_titleNot provided
      • protocol_noECCT/12/11/02
      • version_no1.0
      • date_of_protocol29-02-2012
      • study_drugLopinavir/ritonavir (LPV/r)
      • disease_conditionPlasmodium falciparum (Pf) subclinical parasitemia (SCP).
      • 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_nameAluvia
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaksudoi@hotmail.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_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_applicantAllan K Sudoi
      • declaration_date105-04-2013
      • declaration_principal_investigatorAbraham M Siika, MBChB, MMed, Msc - Site Principal Investigator
      • declaration_date205-04-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Found in section 4.0 of the protocol</p>\n<p>\n 4.1      Step 1 Inclusion Criteria</p>\n<p style=\"margin-left:72.0pt;\">\n 4.1.1   HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left:72.0pt;\">\n Note: The term “licensed” refers to a US FDA-approved kit, which is required for all US sites and recommended for non-US ones. For non-US sites that are unable to obtain an FDA-approved kit, a kit that has been certified or licensed by an oversight body within that country and validated internally is acceptable.</p>\n<p style=\"margin-left:72.0pt;\">\n WHO (World Health Organization) and CDC (Center for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.1.2   CD4+ count > 200 and <u><</u> 350 cells/mm³ obtained within 30 days prior to study entry at a DAIDS-approved laboratory.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.1.3   <em>Pf</em> SCP confirmed in a laboratory approved to conduct parasitemia microscopy.</p>\n<p style=\"margin-left:72.0pt;\">\n Note: <em>Pf</em> SCP will be defined as meeting all three of the following criteria within 72 hours prior to study entry:</p>\n<p style=\"margin-left:115.2pt;\">\n 4.1.3.1   Microscopy confirmed parasitemia (see section 6.3.6 and the A5297 Manual of Procedures [MOPS])</p>\n<p style=\"margin-left:115.2pt;\">\n 4.1.3.2   An oral temperature <u><</u> 37.5^°C temperature</p>\n<p style=\"margin-left:115.2pt;\">\n 4.1.3.3   The absence of Grade 2 or greater signs or symptoms thought to be related to clinical malaria including:</p>\n<p style=\"margin-left:133.2pt;\">\n a.  headache</p>\n<p style=\"margin-left:133.2pt;\">\n b.  malaise or fatigue</p>\n<p style=\"margin-left:133.2pt;\">\n c.  abdominal discomfort</p>\n<p style=\"margin-left:133.2pt;\">\n d.  muscle or joint pain</p>\n<p style=\"margin-left:133.2pt;\">\n e.  fever</p>\n<p style=\"margin-left:133.2pt;\">\n f.   chills</p>\n<p style=\"margin-left:133.2pt;\">\n g.  perspiration</p>\n<p style=\"margin-left:133.2pt;\">\n h.  anorexia</p>\n<p style=\"margin-left:133.2pt;\">\n i.   vomiting</p>\n<p style=\"margin-left:133.2pt;\">\n j.   other signs or symptoms thought to be related to clinical malaria</p>\n<ol>\n <li value=\"NaN\">\n The following laboratory values obtained within 14 days prior to study entry:</li>\n</ol>\n<p style=\"margin-left:115.2pt;\">\n 4.1.4.1   Hemoglobin ³ 7.0 g/dL</p>\n<p style=\"margin-left:115.2pt;\">\n 4.1.4.2   Estimated creatinine clearance of ≥60 mL/min.</p>\n<p style=\"margin-left:115.2pt;\">\n Note: Calculation program can be found on DMC website (<a href=\"http://www.fstrf.org/ACTG/index.html\">http://www.fstrf.org/ACTG/index.html</a>).</p>\n<p style=\"margin-left:115.2pt;\">\n 4.1.4.3   Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) £ 2.5 ´ ULN</p>\n<p style=\"margin-left:72.0pt;\">\n 4.1.5   Hepatitis B surface antigen (HBsAg) negative within 30 days prior to entry.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.1.6   Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test performed within 72 hours prior to entry.  </p>\n<p style=\"margin-left:72.0pt;\">\n NOTE: Female study volunteers of reproductive potential are defined as women who have reached menarche or who have not been post-menopausal for at least 24 consecutive months {i.e., who have had menses within the preceding 24 months and have not undergone a sterilization procedure (eg, hysterectomy, bilateral oophorectomy, or salpingectomy)}.</p>\n<ol>\n <li value=\"NaN\">\n All study volunteers must agree not to participate in a conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for study duration.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n If participating in sexual activity that could lead to pregnancy, all study volunteers must agree to use two reliable forms of contraceptive simultaneously while receiving protocol-specified medications. One form of contraceptive must be a barrier method if a participant receives EFV. Participants must agree to continue the use of two contraceptives for 6 months after stopping EFV and 6 weeks after stopping all other protocol-specified medications.</p>\n<p style=\"margin-left:72.0pt;\">\n Note: Female participants who are unable to meet the contraception requirements for EFV should be encouraged to consider NVP.</p>\n<p style=\"margin-left:72.0pt;\">\n Study volunteers who are not of reproductive potential (girls who have not reached menarche, or women who have been post-menopausal for at least 24 consecutive months, or women who have undergone hysterectomy, bilateral oophorectomy or salpingectomy, or men who have documented azoospermia) are eligible without requiring the use of a contraceptive. Acceptable documentation of sterilization, other contraceptive methods, and menopause are written documentation or oral communication from a clinician or clinician’s staff documented in source documents of one of the following: </p>\n<ul>\n <li>\n Physician report/letter </li>\n <li>\n Operative report or other source documentation in the patient record</li>\n <li>\n Discharge summary</li>\n <li>\n Laboratory report of azoospermia (is required to document successful vasectomy)</li>\n <li>\n FSH measurement elevated into the menopausal range as established by the reporting laboratory for EFV and per participant’s history for all other drugs.</li>\n</ul>\n<ol>\n <li value=\"NaN\">\n Men and women age ³ 18 years.</li>\n <li value=\"NaN\">\n Ability and willingness of participant or legal guardian/representative to provide informed consent.</li>\n <li value=\"NaN\">\n Willing and able to return to the clinic twice to three times a day for study visits.</li>\n</ol>\n<p>\n Step 2: Inclusion Criteria</p>\n<p style=\"margin-left:72.0pt;\">\n 4.2.1   Completion of Step 1</p>\n
      • principal_exclusion_criteria<p>\n 4.3      Step 1: Exclusion Criteria</p>\n<p>\n 4.3.1   Previous history or current use of ART. </p>\n<p>\n 4.3.2   Single dose NVP or dual therapies used for PMTCT within 2 years prior to entry.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.3.3   Use of any medication with antimalarial activity, including TMP/SMX (see list of prohibited medications in the A5297 MOPS), within 14 days prior to study entry. </p>\n<p style=\"margin-left:72.0pt;\">\n 4.3.4   Confirmed or clinically suspected OIs (including but not limited to tuberculosis, clinical malaria, <em>PCP</em>), or other pulmonary or gastrointestinal infections for which potential participants did not complete treatment more than 30 days prior to enrollment or have signs and symptoms during screening.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.3.5   Breastfeeding.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.3.6   Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.3.7   Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.3.8   Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.</p>\n<p style=\"margin-left:72.0pt;\">\n 4.3.9   Results suggestive of active pulmonary disease from a chest x-ray performed within 30 days prior to study entry.</p>\n<p>\n 4.4      Step 2: Exclusion Criteria</p>\n<p>\n There are no exclusion criteria for Step 2</p>\n
      • primary_end_points<p>\n Found in section 9.2 of the protocol</p>\n<p>\n 9.2      Endpoints</p>\n<ol>\n <li value=\"NaN\">\n <p>\n Primary Endpoint</p>\n </li>\n</ol>\n<p style=\"margin-left: 72pt;\">\n <em>Pf</em> SCP clearance defined by PCR < 10 parasites/µL on three consecutive occasions within a 24-hour period, within 15 days of intervention initiation.</p>\n<ol>\n <li value=\"NaN\">\n <p>\n Secondary Endpoints</p>\n </li>\n <li value=\"NaN\">\n <p>\n Batched centralized microscopy defined <em>Pf</em> SCP clearance on three consecutive blood collections.</p>\n </li>\n <li value=\"NaN\">\n <p>\n Time to confirmed <em>Pf</em> SCP clearance (ie, three consecutive negative samples).</p>\n </li>\n <li value=\"NaN\">\n <p>\n Both qualitative (yes/no) and quantitative (gametocytes/µL) <em>Pf</em> gametocyte carriage.</p>\n </li>\n <li value=\"NaN\">\n <p>\n <em>Pf</em> parasite density (parasites/µL) as determined by PCR.</p>\n </li>\n <li value=\"NaN\">\n <p>\n Uncomplicated clinical malaria (defined as the presence of fever/symptoms and parasitemia) (see section 7.1)</p>\n </li>\n <li value=\"NaN\">\n <p>\n <em>Pf</em> plasmepsin 1-4 sequence diversity</p>\n </li>\n</ol>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • scope_efficacy1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Abraham M. Siika MBChB, MMed, MS- Site Leader/ Principal Investigator</p>\n<p>\n Ronald Kibet- MBChB, MSc- Investigator</p>\n<p>\n Charles Kwobah, MBChB- Medical Officer</p>\n<p>\n Mercy Karoney MBChB- Medical Officer</p>\n<p>\n Simon Wachira Njuguna, B Pharm, MPSK - Pharmacist of Record</p>\n<p>\n Kipruto Kirwa, BSc, MPH, PhD- Quality Manager</p>\n<p>\n Priscilla Cheruiyot, BScN, MPH- Site Coordinator</p>\n<p>\n Martha Mokaya, BSc, MBA- Data Manager</p>\n<p>\n Wilson Lokitala Ekiru, BSc IT- Assistant Data Manager</p>\n<p>\n Agnes M. Nzioka, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Betty Meli, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Michael Tanui, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Julie Choge - Recruitment Officer</p>\n<p>\n Dorothy Mwimali - Recruitment Officer</p>\n<p>\n Cecilia Chebet, Dip Counselling - Recruitment Officer</p>\n<p>\n Beatrice Jakait, B Pharm- Back-up Pharmacist</p>\n<p>\n Zipporah Sambili, Dip Pharm- Back-up Pharmaceutical Technologist</p>\n<p>\n Chris Sande, KHRCN- Study Nurse</p>\n
      • other_details_explanation<p>\n Eldoret Kenya is one of the international ACTG sites. The subject under study (malaria) is not prevalent in the USA. The study will therefore be carried out in countries where malaria is endemic.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Moi Teaching and Referral Hospital/Moi University Institutional Research and Ethics Committee (IREC). Approved on 10 September 2012 for Eldoret site only</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationAll participants will be followed for 30 days after randomization.
      • 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_comparatornNRTI-based ART
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites2
      • multi_country_listKenya, Malawi, Uganda and India
      • data_monitoring_committeeYes
      • total_enrolment_per_site20 participants at the Eldoret Site
      • total_participants_worldwide52 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_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • 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_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephone(null)
      • investigator1_email(null)
      • organisations_transferred_No
      • number_participants35 Participants
      • notification
      • approval_date29-02-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-04-2013
      • 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)
      • modified2018-03-26 12:25:24
      • created2013-04-04 15:53:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id61
        • application_id93
        • given_nameAbraham
        • middle_nameMosigisi
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP O Box, 4606-30100, Eldoret
        • telephone(null)
        • email(null)
        • created2013-04-04 16:21:33
        • modified2013-04-05 12:10:55
    • SiteDetail(array)
      • 0(array)
        • id82
        • application_id93
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressAMPATH at MTRH, Nandi Road, Eldoret
        • contact_details+254 53 2060850
        • contact_personAllan Sudoi
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 16:21:33
        • modified2013-04-05 12:10:55
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id47
        • application_id93
        • sponsorNational Institutes of Health
        • sponsor_type(null)
        • contact_person
        • address9000 Rockville Pike Bethesda, Maryland 20892
        • telephone_number301-496-4000
        • fax_number
        • cell_number301-496-4000
        • email_addressNIHinfo@od.nih.gov
        • created2013-04-04 16:21:33
        • modified2013-04-05 12:10:55
  • 2(array)
    • Application(array)
      • id92
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n Areas of high HIV prevalence and intense malaria transmission significantly overlap especially sub-Saharan Africa where a majority of HIV-infected individuals also live in malaria-endemic regions.  Sub-Saharan Africa remains the region most heavily affected by HIV, accounting for 67% of all people living with HIV and 75% of AIDS deaths in 2007.  Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children, in sub-Saharan Africa.                                           </p>\n<p>\n Recent studies have indicated that the interaction between HIV and malaria infection is bi-directional and synergistic. HIV-infected persons are at increased risk for clinical malaria and potential malaria treatment failure. In addition to an apparent increased vulnerability to malaria parasitemia in HIV-infected adults living in malaria endemic regions, malaria may also enhance HIV replication.  Evidence suggests that HIV/malaria coinfection is associated with increased HIV viral load and may therefore impact negatively upon HIV disease progression and/or increase the risk of HIV transmission.  In Kenya, the burden of both HIV and malaria remains significant.  However, while clinic programs and research studies are ongoing targeting HIV and malaria separately, very little if any research is ongoing focusing upon the HIV/malaria co-infection.</p>\n<p>\n Methods used to prevent the spread of malaria disease endemic areas include prophylactic drugs, mosquito eradication, and the prevention of mosquito bites. Attention to non-traditional malaria therapies that may have antimalarial effects is ongoing given the magnitude of malaria related morbidity and mortality.  Identifying drugs, such as PIs used in the treatment of HIV/AIDS (which are becoming more available in sub-Saharan Africa), with antimalarial activity will provide additional tools in comprehensive malaria control and prevention programs.</p>\n<p>\n This study will test the superiority of LPV/r-based ART compared with nNRTI-based ART clearance of <em>Pf</em> SCP.  The primary endpoint is PCR defined clearance of <em>Pf</em> parasitemia on three consecutive occasions within a 24-hour period. HIV-infected participants ≥18 years with CD4+ counts >200 and <u><</u>350 cells/mm³ who will be starting ART and have <em>Pf</em> SCP will be enrolled and randomized to receive either LPV/r or nNRTI-based ART for 15 days. After the 15 day <em>Pf</em> SCP clearance evaluation, all participants will receive nNRTI-based ART plus TMP/SMX prophylaxis to take for 15 days.</p>\n<p>\n The Kericho site will recruit about 20-30 participants, in part dependent upon timing of protocol activation compared to the other 5 sites in this international, multi-center study.  Recruitment will be focused at the Kericho District Hospital HIV clinic.  Nearby health and HIV Testing and Counseling (HTC) facilities under the KEMRI/WRP PEPFAR program will also be utilized.  Participants will be followed for 30 days. The site accrual rate is estimated to be 2-3 participants per month; hence estimated duration of accrual is about 12 months.</p>\n<p>\n  </p>\n<p>\n If PIs are shown to have marked benefit in clearance of subclinical malaria, such information would be informative to both clinical researchers (i.e. KEMRI) in considering future HIV/malaria infection research as well as policy stakeholders (i.e. Ministry of Health) in considering optimal treatment and prevention initiatives.</p>\n
      • study_title<p align=\"center\">\n  </p>\n<p style=\"text-align: justify;\">\n <strong>An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of </strong></p>\n<p style=\"text-align: justify;\">\n <strong><em>Plasmodium falciparum</em></strong><strong> Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and <u><</u>350 cells/mm³</strong> .</p>\n
      • laymans_summary<p>\n The areas that has highest problems of HIV infection, also experiences the biggest burden of malaria. Sub-Saharan Africa remains the region most heavily affected by HIV.  Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children, in sub-Saharan Africa. Methods used to prevent the spread of malaria disease endemic areas include prophylactic drugs, mosquito eradication, and the prevention of mosquito bites. Attention to non-traditional malaria therapies that may have antimalarial effects is ongoing given the magnitude of malaria related morbidity and mortality.  Identifying drugs, such as those used in the treatment of HIV/AIDS (which are becoming more available in sub-Saharan Africa), with antimalarial activity will provide additional tools in comprehensive malaria control and prevention programs</p>\n
      • short_titleHIV-Malaria Study_A5297
      • protocol_noECCT/13/04/03
      • version_noVersion 1.0
      • date_of_protocol29-02-2012
      • study_drugefavirenz (EFV), nevirapine (NVP), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/r), and trimethoprim/sulfamethoxazole (TMP/SMX) DS.
      • disease_conditionHIV and Malaria
      • 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_nameefavirenz (EFV), nevirapine (NVP), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/r), and trimethoprim/sulfamethoxazole (TMP/SMX) DS.
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjosphat.kosgei@usamru-k.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_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_applicantKEMRI Walter Reed Project. P.O. Box 1357-20200 Kericho
      • declaration_date108-04-2013
      • declaration_principal_investigatorDr Josphat Kiprop Kosgei, Principal Investigator.
      • declaration_date208-04-2013
      • placebo_presentNo
      • study_objectives<div>\n Primary Objective</div>\n<div>\n To compare the proportions of Pf SCP clearance between LPV/r-based and</div>\n<div>\n nNRTI based ART in participants after 15 days of therapy (Step 1).</div>\n<div>\n 1.4 Secondary Objectives</div>\n<div>\n 1.4.1 To compare time to Pf SCP clearance in participants with Pf SCP who have</div>\n<div>\n received 15 days of LPV/r-based and nNRTI-based ART.</div>\n<div>\n 1.4.2 To compare Pf parasite densities in participants with Pf SCP who have received</div>\n<div>\n 15 days of LPV/r-based and nNRTI-based ART.</div>\n<div>\n 1.4.3 To estimate changes in Pf parasite densities from day 1 to day 30 in four cohorts:</div>\n<div>\n (1) randomized to nNRTI-based ART with continued Pf SCP at day 15, (2)</div>\n<div>\n randomized to nNRTI-based ART with clearance of Pf SCP at day 15, (3)</div>\n
      • principal_inclusion_criteria<p style=\"margin-left: 1in;\">\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n Note: The term “licensed” refers to a US FDA-approved kit, which is required for all US sites and recommended for non-US ones. For non-US sites that are unable to obtain an FDA-approved kit, a kit that has been certified or licensed by an oversight body within that country and validated internally is acceptable.</p>\n<p style=\"margin-left: 1.5in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n WHO (World Health Organization) and CDC (Center for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n CD4+ count > 200 and <u><</u> 350 cells/mm³ obtained within 30 days prior to study entry at a DAIDS-approved laboratory.</p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n <em>Pf</em> SCP confirmed in a laboratory approved to conduct parasitemia microscopy.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n Note: <em>Pf</em> SCP will be defined as meeting all three of the following criteria within 72 hours prior to study entry:</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1.6in;\">\n Microscopy confirmed parasitemia (see section 6.3.6 and the A5297 Manual of Procedures [MOPS])</p>\n<p style=\"margin-left: 1.6in;\">\n  </p>\n<p style=\"margin-left: 1.6in;\">\n An oral temperature <u><</u> 37.5^°C temperature</p>\n
      • principal_exclusion_criteria<p>\n Previous history or current use of ART. </p>\n<p>\n  </p>\n<p>\n Single dose NVP or dual therapies used for PMTCT within 2 years prior to entry.</p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n Use of any medication with antimalarial activity, including TMP/SMX (see list of prohibited medications in the A5297 MOPS), within 14 days prior to study entry. </p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n Confirmed or clinically suspected OIs (including but not limited to tuberculosis, clinical malaria, <em>PCP</em>), or other pulmonary or gastrointestinal infections for which potential participants did not complete treatment more than 30 days prior to enrollment or have signs and symptoms during screening.</p>\n
      • primary_end_points<p>\n The primary endpoint is PCR defined clearance of <em>Pf</em> parasitemia defined as < 10 parasites/µL on three consecutive occasions within a 24-hour period.</p>\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_others1
      • scope_others_specifyProof of Concept
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<h1>\n 1SITE INVESTIGATORS AND CONTACT INFORMATION</h1>\n<p>\n  </p>\n<p>\n <strong>A) Site Principal Investigator</strong></p>\n<p>\n Dr Josphat K Kosgei, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 729 110122</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: josphat.kosgei@usamru-k.org</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>B) Associate Investigators</strong></p>\n<p>\n Dr Fredrick K Kirui, MBBS, MPH, MMed</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531 373</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">fredrick.kirui@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n Dr Deborah C Langat, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 714 059596</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">deborah.langat@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Dr Kathleen C. Rono, MBChB, MPH & TM</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">krono@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Dr Lucy Koech, MBChB,</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 719 193275</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">lucy.</a>koech@usamru-k.org</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Dr Fredrick K. Sawe, MBChB, MMED</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 724 255623</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">fsawe@wrp-kch.org, fsawe@hivresearch.org</a></p>\n<p>\n  </p>\n<p>\n Dr Douglas N. Shaffer, MD, MHS</p>\n<p>\n United States Army Medical Research Unit-Kenya</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546</p>\n<p>\n  </p>\n<p>\n <strong>C) Pharmacist</strong></p>\n<p>\n Dr. Noah K. Tarus, B Pharm, MSc</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 30388</p>\n<p>\n Mobile: +254 713 603222</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:ntarus@wrp-kch.org\">noah.tarus@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n <strong>D) Laboratory Director</strong></p>\n<p>\n Dr Kibet Shikuku, MBChB, MMed</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555537</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">kibet.shikuku@usamru-k.org</a></p>\n<p>\n <strong>E) Data Manager</strong></p>\n<p>\n Ignatius Kiptoo</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531375</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">ignatius.kiptoo@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n <strong>F) Study Coordinator</strong></p>\n<p>\n Hellen Ngeno, BSN</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 713 603225</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:hngeno@wrp-kch.org\">hngeno@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>G) Local DoD Research  Monitor</strong></p>\n<p>\n <u>Primary DoD Research Monitor</u></p>\n<p>\n  </p>\n<p>\n Dr. Appolonia Aoko, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 715 551234</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:aaoko@wrp-kch.org\">aaoko@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Alternate DoD Research Monitor</p>\n<p>\n  </p>\n<p>\n Dr. Jonah Maswai, MBChB, MPH</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 716 430271</p>\n
      • other_details_explanation<p>\n Kenya has a high prevalence of both HIV and Malaria, which is a requirement of the study.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute (KEMRI) Ethical Research Committee. Approval date 26 March 2013. This is for Kericho site only.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable.</p>\n
      • estimated_durationOne year
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNNRTI arm
      • design_controlled_other_medicinalNo
      • 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_countriesYes
      • multiple_member_states4
      • number_of_sites2
      • multi_country_listKenya, Botswana, Malawi, India
      • data_monitoring_committeeYes
      • total_enrolment_per_site20-30
      • total_participants_worldwide52
      • 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_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • 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_nameDavid
      • investigator1_middle_nameC.
      • investigator1_family_nameWekulo
      • investigator1_qualificationBScN
      • investigator1_professional_addressKEMRI WRP P.O. Box 1357-20200 Kericho
      • investigator1_telephone254729110146
      • investigator1_emaildavid.wekulo@usamru-k.org
      • organisations_transferred_Yes
      • number_participants20-30
      • notification
      • approval_date26-03-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to</div>\n<div>\n test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to nonnucleoside reverse</div>\n<div>\n transcriptase (nNRTI)-based ART for clearance of Plasmodium falciparum (Pf) subclinical parasitemia (SCP).</div>\n<div>\n Participants were followed for 30 days in order to evaluate parasitemia clearance, Pf parasitemia, gametocytemia,</div>\n<div>\n and plasmepsin sequencing. Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and</div>\n<div>\n three times for day 15 and day 30.</div>\n<div>\n Fifty-two participants (26 per arm) enrolled between January 10, 2014 and May 20, 2016 with 46 (88%) from two</div>\n<div>\n sites in Kenya. Fifty-one participants completed the primary outcome (Step 1) visit, and 49 completed the protocol</div>\n<div>\n as specified. The study population was mostly male (67%) with a median age of 31 (Q1, Q3=24, 39) years. The</div>\n<div>\n median baseline CD4 count was 324 cells/mm3 (259, 404) and median baseline log10 (HIV-1 RNA) was 5.18</div>\n<div>\n copies/mL (4.60, 5.71). The median baseline parasite density was 2.66 log10 parasites/μL (1.92, 3.35) (Table 1).</div>\n<div>\n For the primary outcome, there was no statistically significant difference in clearance between the LPV/r-based</div>\n<div>\n (n=6, 23%) and nNRTI-based (7, 27%) ART arms (Table 2). Sensitivity analyses were conducted around missing data:</div>\n<div>\n one where missing data were assumed to have cleared and one where missing data were excluded. Sensitivity</div>\n<div>\n analyses were also conducted using less stringent definitions of clearance: one where participants were considered</div>\n<div>\n cleared if any 2 of 3 samples had <10 estimated parasites/μL at day 15 by qRT-PCR and one where participants</div>\n<div>\n were considered cleared if any 1 of 3 samples had < 10 parasites/μL at day 15 by qRT-PCR. In all sensitivity</div>\n<div>\n analyses, the difference in clearance between the treatment arms remained non-significant.</div>\n<div>\n Secondary objective analyses included time-to–Pf parasite clearance, between-arm parasite densities over time,</div>\n<div>\n and safety outcomes. No statistically significant differences in time-to-Pf 9 parasite clearance were observed</div>\n<div>\n between arms (P=0.80, Figure 2). Mean Pf parasite densities through the 30-day study window were examined</div>\n<div>\n (Figure 3). While overall, a trend was observed in decreasing Pf parasite densities in both arms throughout the</div>\n<div>\n study, there was no difference between the two treatment arms during days 1-15 (LPV/r Arm median = -0.61 [Q1,</div>\n<div>\n Q3 = -1.78,0.00] and nNRTI Arm -0.46 [-1.31,0.41]) or days 15-30 (LPV/r Arm -1.04 [-2.39,-0.67] and nNRTI Arm -</div>\n<div>\n 1.40 [-2.51,-0.52]). Overall, Pf parasite density decreased between entry and day 30 (-2.36 [-3.46,-0.94]); at the</div>\n<div>\n same time median CD4 counts increased (101 cells/mm3) and median log10 HIV RNA decreased (-2.48 copies/mL)</div>\n<div>\n with no significant between arm differences.</div>\n<div>\n During the study period, there were few adverse events with no hospitalizations. Three cases of uncomplicated,</div>\n<div>\n Grade 2 clinical malaria (LPV/r Arm n=2, nNRTI Arm n=1) occurred during Step 1, and all received SOC</div>\n<div>\n artemether/lumefantrine. One participant in both treatment arms experienced Grade 2 anemia (n=2).</div>\n<div>\n The Study’s results did not find a statistically significant difference in parasite clearance rates nor in time-toparasite</div>\n<div>\n clearance between PI and nNRTI treatment arms. To the Study’s knowledge, the proof-of-concept RCT of</div>\n<div>\n HIV-infected adults beginning first-line ART with Pf SCP is the first direct comparison between a PI (LPV/r) and</div>\n<div>\n nNRTI.</div>\n
      • implication_results<div>\n Yes, from the Primary Manuscript:</div>\n<div>\n  The Study’s results did not find a statistically significant difference in parasite clearance rates</div>\n<div>\n nor in time-to-parasite clearance between PI and nNRTI treatment arms. To the Study’s knowledge, the</div>\n<div>\n proof-of-concept RCT of HIV-infected adults beginning first-line ART with Pf SCP is the first direct</div>\n<div>\n comparison between a PI (LPV/r) and nNRTI.</div>\n<div>\n  The Study provides a unique cohort testing the clinical impact of PIs in a setting without and with</div>\n<div>\n TMP/SMX. While participants had CD4 counts >200 given requirements for TMP/SMX in people with lower</div>\n<div>\n CD4 counts, the Study observed no complicated malaria, PCP, or diarrheal disease.</div>\n<div>\n  Three cases of uncomplicated malaria (parasitemia and fever) during the first 15 days in the absence of</div>\n<div>\n TMP/SMX. This likely reflects fluctuations in SCP in the absence of TMP/SMX and occasional fever</div>\n<div>\n threshold densities being passed.</div>\n<div>\n  This Study also provides unique opportunity for further investigation into parasite and gametocyte life</div>\n<div>\n cycles and kinetics.</div>\n
      • quantity_importedFind attached product accountability documents
      • quantity_dispensedFind attached product accountability documents
      • quantity_destroyedFind attached product accountability documents
      • quantity_exportedFind attached product accountability documents
      • balance_siteFind attached product accountability documents
      • final_date0000-00-00
      • modified2025-02-25 13:18:04
      • created2013-04-04 14:58:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id60
        • application_id92
        • given_nameJosphat
        • middle_nameK.
        • family_nameKosgei
        • qualificationMBChB
        • professional_addressKEMRI WRP P.O. Box 1357-20200 Kericho
        • telephone254729110122
        • emailjosphat.kosgei@usamru-k.org
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
    • SiteDetail(array)
      • 0(array)
        • id80
        • application_id92
        • county_id35
        • site_nameKemri Walter Reed Project-Kericho
        • physical_addressHospital road
        • contact_detailsP.O. Box 1357-20200
        • contact_personJosphat Kosgei
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id83
        • application_id92
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressMoi Teaching Referral Hospital Building, Nandi Road, Eldoret, Kenya
        • contact_detailsP.O. Box 4604 - 30100 Kenya Tel:254-53 2060850
        • contact_personRonald Kibet
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 17:36:47
        • modified2020-03-17 12:04:08
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id46
        • application_id92
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_personBeverly Alston-Smith, MD
        • address6700 B Rockledge Drive, Room 5109 Bethesda, MD 20892-7605
        • telephone_number301-435-3773
        • fax_number301-480-4582
        • cell_number301-435-3773
        • email_addressbalston@niaid.nih.gov
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
  • 3(array)
    • Application(array)
      • id91
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n Tuberculosis (TB) is a major public health problem in the world and is the leading AIDS related opportunistic infection. 2009World Health Organization (WHO) data collection estimated that there were 9.4 million new incident cases of tuberculosis. Among new incident cases of TB, 1.1million (11%) were HIV co-infected and 35% of TB deaths were among HIV co-infected individuals. Kenya is one of the 22 high TB burden countries in the world which collectively contribute 80% of the global TB disease burden. In Kenya, 106,083 cases of TB were reported in the year 2010. HIV infection contributes significantly to an increased risk of progression of Latent TB infection (LTBI) to active TB. Isoniazid taken for 6-9 months has been the cornerstone of treatment for LTBI to prevent active TB for more than 30 years though this has been associated with high proportion of individuals who fail to complete even 6 months of isoniazid preventive therapy. This highlights the need for alternative, more effective short-course approaches for treatment of LTBI. This study will compare a 4 week daily rifapentine/isoniazid regimen to a standard 9 month daily isoniazid regimen for the prevention of TB in HIV infected participants without evidence of active TB. The primary objective will be efficacy of TB prevention. HIV infected participants of ≥18years will be randomized to receive either  rifapentine/isoniazid for 4 weeks daily or isoniazid  for 36 weeks daily. Safety and tolerability of the regimens, adherence to treatments and patterns of antibiotic resistance among Mycobacterium tuberculosis isolates in participants who fail on these prophylactic regimens will be assessed. The Kericho site will recruit about 100 participants. Recruitment will be done from Kericho District Hospital HIV clinic and nearby health facilities. All enrolled participants will be followed up for 156 weeks after the last participant is enrolled. The site accrual rate is estimated to be 6 participants per month; hence estimated duration of accrual is about 2years.If ultra short course rifapentine/isoniazid is more efficacious than standard 9 months isoniazid, this information will be passed to the Ministry of Health which will help in making policies on the appropriate use of the new regimen in various TB control</p>\n
      • study_title<p>\n  </p>\n<p>\n <strong>Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals with Latent Tuberculosis Infection</strong></p>\n
      • laymans_summary<p>\n Tuberculosis (TB) is a major public health problem in the world and is the leading AIDS related opportunistic infection (infection that is normally mild in a healthy person, but takes advantage of an ill person's weakened immune system to move into the body, multiply, spread, and cause serious illness) hence the need to prevent active TB by treating latent TB. Kenya is one of the 22 high TB burden countries in the world which collectively contribute 80% of the global TB disease burden. Some people are infected with the bacteria that cause TB, but their immune systems (the system in a person’s body that helps fight infections) prevent the bacteria from multiplying and they do not have any symptoms from the infection; these people are said to have latent TB infection. Latent TB can develop into active disease and cause sickness, especially in people with weakened immune systems, such as those with HIV. The standard way to keep latent TB from becoming active is treatment with 6 to 9 months of daily isoniazid, an anti-TB drug. In Kenya the standard treatment is use of isoniazid for 6 months. This has been associated with high proportion of individuals who fail to complete even 6 months of isoniazid preventive therapy. This highlights the need for alternative, more effective short-course approaches for treatment of Latent Tuberculosis infection. This study will compare a 4 week daily rifapentine/isoniazid regimen to a standard 9 month daily isoniazid regimen for the prevention of TB in HIV infected participants without evidence of active TB. The primary objective will be efficacy of TB prevention. HIV infected participants of ≥18years will be randomly assigned to receive either  rifapentine/isoniazid for 4 weeks daily or isoniazid  for 36 weeks daily. The Kericho site will recruit about 150 participants. Recruitment will be done from Kericho District Hospital HIV clinic and nearby health facilities. All enrolled participants will be followed up for 156 weeks after the last participant is enrolled. If ultra short course drug treatment of rifapentine/isoniazid is not inferior than standard 9 months isoniazid in prevention of active TB, this information will be shared with the Ministry of Health who will help in making policies on the appropriate use of the new regimen in prevention of active TB.</p>\n
      • short_titleShort-course RPT/INH for latent TB in HIV-infected individuals
      • protocol_noECCT/13/04/09
      • version_noversion 1.0
      • date_of_protocol11-05-2011
      • study_drugRifapentine and Isoniazid
      • disease_conditionTuberculosis
      • 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_nameRifapentine and Isoniazid
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameIsoniazid
      • comparator_registeredyes
      • comparator_countriesKenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdeborah.langat@usamru-k.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_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • 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_applicantDeborah C. Langat
      • declaration_date111-04-2013
      • declaration_principal_investigatorDeborah C. Langat
      • declaration_date211-04-2013
      • placebo_presentNo
      • study_objectives<p>\n PRIMARY OBJECTIVE</p>\n<ol>\n <li>\n To compare the efficacy of a 4-week daily regimen of weight-based RPT/INH to a standard 9-month (36 week) daily INH regimen for TB prevention in HIV-infected individuals.</li>\n</ol>\n<p>\n SECONDARY OBJECTIVES</p>\n<ol>\n <li>\n To compare safety and tolerability of the regimens</li>\n <li>\n To compare overall and non-TB mortality rates among participants receiving the two regimens</li>\n <li>\n To compare adherence rates in the two regimens</li>\n <li>\n To investigate patterns of antibiotic resistance among Mycobacterium tuberculosis (MTB) isolates in participants failing prophylaxis</li>\n <li>\n To inform public health policy by comparing estimated costs and cost-effectiveness of the two regimens in various populations</li>\n <li>\n To investigate the effect of RPT/INH on efavirenz (EFV) and nevirapine (NVP) plasma concentrations</li>\n <li>\n To describe exposure-outcome relationships among EFV and NVP pharmacokinetic (PK) parameters and virologic failure, and safety and tolerance related to EFV and NVP</li>\n <li>\n To investigate relationships among genetic characteristics of drug metabolizing enzymes and drug transporters and the PK characteristics of EFV, NVP, and RPT.</li>\n <li>\n To determine the PK characteristics of EFV and its 7-OH-EFV and 8-OH-EFV metabolites when given in combination with RPT+INH (Arm A) and when given with INH alone (Arm B).</li>\n <li>\n To compare EFV PK data obtained from combination therapy with RPT+INH and INH alone with a control group consisting of a set of plasma samples with participants receiving ART containing EFV but not RPT or INH, which will be collected from individuals in Arm A who have completed RPT/INH therapy and have allowed for a washout period.</li>\n</ol>\n
      • principal_inclusion_criteria<p>\n  </p>\n<p>\n 1.      HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load; for the Kericho site, HIV-1 infection will be confirmed based upon 2 consecutive Elisa and a Western Blot </p>\n<p>\n 2.      TST reactivity ≥5 mm, or a positive interferon gamma release assay (IGRA) at any time prior to study entry, OR living in a high TB burden area</p>\n<p>\n NOTE: High TB burden areas are defined as countries with all cases of TB prevalence ≥60/100,000/year of the country’s population, according to WHO. Kenya is one of the countries with high TB burden, and therefore we shall use the later criteria to enroll our participants at the Kericho site.</p>\n<p>\n 3.      Laboratory values obtained within 30 days prior to entry</p>\n<p style=\"margin-left:1.0in;\">\n §  Absoluteneutrophil count (ANC) >750 cells/mm³</p>\n<p style=\"margin-left:1.0in;\">\n §  Hemoglobin 7.4 g/dL</p>\n<p style=\"margin-left:1.0in;\">\n §  Platelet count 50,000/mm³</p>\n<p style=\"margin-left:1.0in;\">\n §  Aspartate aminotransferase (AST) (serum glutamicoxaloacetictransaminase [SGOT]) and alanineaminotransferase (ALT) (serum glutamicpyruvictransaminase [SGPT]) ≤3 X upper limit of normal (ULN)</p>\n<p style=\"margin-left:1.0in;\">\n §  Total bilirubin ≤2.5 X ULN</p>\n<p>\n 4.      Female participants of reproductive potential must have a negative serum or urine pregnancy test performed within 7 days prior to study entry.</p>\n<p>\n NOTE: Female participants of reproductive potential are defined as women who have reached menarche or who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).</p>\n<p>\n 5.      All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization) while receiving RPT and for 6 weeks after stopping this drug.</p>\n<p>\n 6.      Female participants who are participating in sexual activity that could lead to pregnancy must agree to use one reliable non-hormonal form of contraceptive (i.e., condoms, with a spermicidal agent; a diaphragm or cervical cap with spermicide; or an IUD) while receiving RPT and for 6 weeks after stopping this drug. For male candidates, they must agree to use condoms. Participants will receive family planning services at their primary Health care providers or at the KEMRI/WRP CRC.</p>\n<p>\n NOTE: Female participants who are not of reproductive potential, as defined above, or whose male partner(s) have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives. Participant-reported history is acceptable documentation of menopause, hysterectomy, or bilateral oophorectomy or bilateral tubal ligation.</p>\n<p>\n 7.      Men and women age ³18 years</p>\n<p>\n 8.      Weight ≥30 kg</p>\n<p>\n 9.      Ability and willingness of participant to provide informed consent</p>\n<p>\n  </p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<h3>\n  </h3>\n
      • principal_exclusion_criteria<p>\n  </p>\n<p>\n 1.      Treatment for active or latent TB (pulmonary or extrapulmonary) within 2 years prior to study entry or, at screening, presence of any confirmed or probable TB based on criteria listed in the current ACTG Diagnosis Appendix</p>\n<p>\n 2.      History of multi-drug resistant (MDR) or extensively-drug resistant (XDR) TB at any time prior to study entry</p>\n<p>\n 3.      Known exposure to MDR or XDR TB (e.g., household member of a person with MDR or XDR TB) at any time prior to study entry</p>\n<p>\n 4.      Treatment for >14 consecutive days with a rifamycin or >30 consecutive days with INH at any time during the 2 years prior to enrollment</p>\n<p>\n 5.      For participants taking ART, only NRTI- and NNRTI-based regimens will be allowed at study entry and during the first 4 weeks of study treatment with RPT. Treatment with any other ART regimen (e.g., PI-based, raltegravir-containing) at study entry or plans to initiate such a regimen during the first 4 weeks of study treatment is exclusionary. Participants must have been on their current ART regimen for at least 4 weeks.</p>\n<p>\n NOTE: Participants taking NVP will not be eligible to enroll until the A5279 team has reviewed the PK data on those participants taking EFV and determined that it is safe to enroll participants taking NVP. The team will send a memo to sites notifying them if and when participants taking NVP are eligible to enroll.</p>\n<p>\n 6.      History of liver cirrhosis at any time prior to study entry</p>\n<p>\n 7.      Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or light stools within 90 days prior to entry</p>\n<p>\n 8.      Diagnosis of porphyria at any time prior to study entry</p>\n<p>\n 9.      Peripheral neuropathy ≥Grade 2 according to the December 2004 (Clarification, August 2009) Division of AIDS (DAIDS) Toxicity Table, within 90 days prior           to study entry</p>\n<p>\n 10.  Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation</p>\n<p>\n 11.  Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements</p>\n<p>\n 12.  Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.</p>\n<p>\n 13.  Breastfeeding</p>\n
      • primary_end_points<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:times new roman,times,serif;\">Time from randomization to first diagnosis of active TB</span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • 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<p>\n  </p>\n<p>\n <strong>A) Site Principal Investigator</strong></p>\n<p>\n Dr. Deborah C. Langat, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 714059596</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:dchepngeno@wrp-kch.org\">dchepngeno@wrp-kch.org</a></p>\n<p>\n <strong>B) Co- Principal Investigator,</strong></p>\n<p>\n Dr. Fredrick K. Sawe, MBChB, MMED</p>\n<p>\n Deputy Director, HIV Research and Treatment</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 724 255623</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">fsawe@wrp-kch.org</a></p>\n<p>\n C) <strong>Associate Investigator,</strong></p>\n<p>\n Dr. Douglas N. Shaffer, MD, MHS, FACP</p>\n<p>\n Director, United States Army Medical Research Unit-Kenya/ Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254-52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 724 255620</p>\n<p>\n Fax: +254 52 30662 /+254 052 30546</p>\n<p>\n Email: <a href=\"mailto:dshaffer@wrp-kch.org\">dshaffer@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Dr. Fredrick K. Kirui, MBBS, MPH, MMED</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 - 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel +254-52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531373</p>\n<p>\n Fax: + 254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:fkkirui@wrp-kch.org\">fkkirui@wrp-kch.org</a>.</p>\n<p>\n  </p>\n<p>\n Dr. Josphat K. Kosgei, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 - 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 729 110122</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">jkosgei@wrp-kch.org</a>.</p>\n<p>\n  </p>\n<p>\n Dr. Kathleen C. Rono, MBChB, MPH & TM</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <u>krono</u><a href=\"mailto:jkosgei@wrp-kch.org\">@wrp-kch.org</a>.</p>\n<p>\n  </p>\n<p>\n Dr. Kibet P. Shikuku, MBChB, MMED</p>\n<p>\n Laboratory Director,</p>\n<p>\n Kenya Medical Research Institute/Walter Reed</p>\n<p>\n Project HIV Program Clinical Research Center</p>\n<p>\n Laboratory</p>\n<p>\n P.O. Box 1357 - 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile phone: + 254 720 789843</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n E-mail: <a href=\"mailto:kshikuku@wrp-kch.org\">kshikuku@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Ignatius K. Ngetich, BSc, MS</p>\n<p>\n Kenya Medical Research Institute/Walter Reed</p>\n<p>\n Project HIV Program Information Technology</p>\n<p>\n Department Head,</p>\n<p>\n P.O. Box 1357 - 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile phone: +254 727 531375</p>\n<p>\n  Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n E-mail: <a href=\"mailto:ikiptoo@wrp-kch.org\">ikiptoo@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>D) Head of Microbiology</strong>,</p>\n<p>\n Sheilla J. Chebore, BSc, MSc</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 714 058603</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:schebore@wrp-kch.org\">schebore@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>E) Pharmacist,</strong></p>\n<p>\n Dr. Noah K. Tarus, B Pharm, MSc</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 30388</p>\n<p>\n Mobile: +254 713 603222</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:ntarus@wrp-kch.org\">ntarus@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Dr. Joel K. Chebon, B Pharm</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 30388</p>\n<p>\n Mobile: +254 705000953</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:Jchebon@wrp-kch.org\">Jchebon@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>F) Study Coordinator,</strong></p>\n<p>\n Christopher K. Kimetto, KRCHN, Diploma</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 702 119192</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:ckimetto@wrp-kch.org\">ckimetto@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>G) Local DoD Research Monitors</strong></p>\n<p>\n <strong>Primary Monitor</strong></p>\n<p>\n Dr. Jonah K. Maswai, MBChB, MPH</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 716430271</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:jmaswai@wrp-kch.org\">jmaswai@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>Alternate Monitors</strong></p>\n<p>\n Dr. Appolonia A. Onyango, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 715551234</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:aaoko@wrp-kch.org\">aaoko@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Dr. Teresa Simiyu, MBChB, MSc</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 720334054</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:tsimiyu@wrp-kch.org\">tsimiyu@wrp-kch.org</a></p>\n<p>\n Please see also page 60 of the Site Specific Addendum Apendix II, KEMRI/WRP Roles of Study Personnel</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n  </p>\n<p style=\"margin-left:.1in;\">\n <strong>Walter Reed Army Institute of Research IRB.</strong></p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute Ethics Review Committee (KEMRI ERC) approved on 26 Mar 2013.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationThe site estimated duration of accrual is about 2 years and all participants will be followed for 3 years after enrollment of the last participant.
      • 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_comparatorIsoniazid
      • design_controlled_other_medicinalNo
      • 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_countriesYes
      • multiple_member_states15
      • number_of_sites2
      • multi_country_listKenya, Zimbabwe, India, South Africa, Brazil, Argentina, Botswana, Peru, Thailand, Malawi, Haiti, USA, Uganda, Zambia, Tanzania
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKEMRI WRP Kericho - 100 participants\nAmpath Moi University - 300 participants
      • total_participants_worldwide3000
      • 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_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameChristopher
      • investigator1_middle_nameK.
      • investigator1_family_nameKimetto
      • investigator1_qualificationKRCHN, Diploma
      • investigator1_professional_addressKEMRI/ WRP P.O BOX 1357 - 20200 Kericho
      • investigator1_telephone052 2036100
      • investigator1_emailchristopher.kimetto@usamru-k.org
      • organisations_transferred_Yes
      • number_participants400
      • notification<p>\n The attached files in section 14 are</p>\n<p>\n 1. A5279 Kiswahili ICF version 1.5 dated 06 Mar 2013</p>\n<p>\n 2. CV for Dr. Fredrick Sawe</p>\n<p>\n 3. A5279 Participant summary sheet both english and kiswahili dated 22 Oct 2012</p>\n<p>\n 4. Amendement to Rifapentine Investigator's Brochure</p>\n<p>\n 5. Package insert for Isoniazid dated Sep 2011.</p>\n
      • approval_date26-03-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The study was opened to accrual on 02 May 2012. Kericho site got activated on 27 Jan 2014 and started screening and enrollment on 28 Jan 2014 after all approvals were received. In Kericho a total of 98 participants were consented and screened and out of the 98 participants screened, 90 participants were enrolled, 8 were ineligible for the study. Of the 90 participants enrolled, 2 were withdrawn from the study (1 Withdrawn from the study because of non-compliance with protocol visits and 1 withdrawn from the study because of not starting study medication within 72 hours after randomization as per protocol), 1 participant withdrew from the study because she was moving from the study site and wanted to continue care and treatment at a local health facility and 2 participants died. The study was closed to accrual on 12 Nov 2014 after the target sample size of 3000 was achieved and all participants have completed the study follow up as per the protocol. The last study visit at the site was on 10 November 2017.</p>\n<p style=\"margin-left:.05in;\">\n <strong><u>RESULTS</u></strong></p>\n<p style=\"margin-left:.05in;\">\n A total of 3000 patients were enrolled and followed for a median of 3.3 years. Of these patients, 54% were women; the median CD4+ count was 470 cells per cubic millimeter, and half the patients were receiving antiretroviral therapy. The primary end point was reported in 32 of 1488 patients (2%) in the 1-month group and in 33 of 1498 (2%) in</p>\n<p style=\"margin-left:.05in;\">\n the 9-month group, for an incidence rate of 0.65 per 100 person-years and 0.67 per 100 person-years, respectively (rate difference in the 1-month group, −0.02 per 100 person years; upper limit of the 95% confidence interval, 0.30). Serious adverse events occurred in 6% of the patients in the 1-month group and in 7% of those in the 9-month group</p>\n<p style=\"margin-left:.05in;\">\n (P = 0.07). The percentage of treatment completion was significantly higher in the 1-month group than in the 9-month group (97% vs. 90%, P<0.001).</p>\n<p style=\"margin-left:.05in;\">\n <u>CONCLUSIONS</u></p>\n<p>\n A 1-month regimen of rifapentine plus isoniazid was noninferior to 9 months of isoniazid alone for preventing tuberculosis in HIV-infected patients. The percentage of patients who completed treatment was significantly higher in the 1-month group.</p>\n<p style=\"margin-left:3.75pt;\">\n <u>Manuscripts</u></p>\n<ul>\n <li>\n One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis. Published in the New England Journal of Medicine.</li>\n <li>\n Applying a Risk-benefit Analysis to Outcomes in Tuberculosis Clinical Trials. Published in Clinical Infectious Diseases Journal.</li>\n <li>\n Efavirenz Pharmacokinetics and Pharmacodynamics in HIV-Infected Persons Receiving Rifapentine and Isoniazid for Tuberculosis Prevention. Published in Clinical Infectious Diseases Journal.</li>\n</ul>\n<p style=\"margin-left:3.75pt;\">\n <u>Abstracts</u></p>\n<ul>\n <li>\n One month of Rifapentine/Isoniazid to prevent TB in people with HIV- BRIEF-TB/ A5279. Oral Abstract in CROI 2018</li>\n <li>\n Adverse Pregnancy Outcomes Among HIV infected women exposed to Isoniazid one month of Rifapentine/Isoniazid in BRIEF-TB. Presented as Oral Abstract in CROI 2021</li>\n <li>\n Efavirenz pharmacokinetics in HIV+ persons receiving rifapentine and isoniazid for TB prevention</li>\n</ul>\n<p>\n Study documents have been transferred to a safe, secured, long-term archive room that is only accessible to regulatory personnel. All other research staff do not have access to this archive room. Access to study documents is controlled and restricted and the site is responsible for ensuring that any access is accurately recorded and any documents accessed/removed and returned are recorded. Destruction approval will be obtained from the sponsor and the IRBs will be notified when this is done.</p>\n<p>\n There are currently no plans for future analysis of individual participant data by study site personnel. Analysis of aggregated data and publication for secondary objectives will continue. Any plans for future (non-aggregated) analyses will be reviewed and approved by KEMRI SERU and PPB ECCT prior to the work being completed.</p>\n<p>\n There are no samples stored at the site, all samples were shipped to the US for analysis and for storage indefinitely as per the approved protocol. Future use of the stored samples will have to be reviewed and approved by KEMRI SERU and PPB ECCT.  </p>\n<p>\n The study results have been communicated to the local community through continuous medical education and meeting with the community Advisory Board as well as meetings organized in the community. This was done after the primary manuscript of One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis was published. </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • implication_results<p>\n Yes, from the manuscripts;</p>\n<p>\n  </p>\n<ul style=\"list-style-type:circle;\">\n <li>\n Results showed that 1-month regimen of rifapentine plus isoniazid was noninferior to 9 months of isoniazid alone for preventing tuberculosis in HIV-infected patients. The percentage of patients who completed treatment was significantly higher in the 1-month group</li>\n</ul>\n<p>\n  </p>\n<ul style=\"list-style-type:circle;\">\n <li>\n Four weeks of daily rifapentine plus isoniazid can be co-administered with efavirenz without clinically meaningful reductions in efavirenz mid-dosing concentrations or virologic suppression.</li>\n</ul>\n<p>\n  </p>\n
      • quantity_imported
      • quantity_dispensed
      • quantity_destroyed
      • quantity_exported
      • balance_site
      • final_date0000-00-00
      • modified2022-08-27 11:50:12
      • created2013-04-04 14:30:03
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id59
        • application_id91
        • given_nameDeborah
        • middle_nameC.
        • family_nameLangat
        • qualificationMBchB
        • professional_addressKEMRI/ WRP P.O BOX 1357 - 20200 Kericho
        • telephone0522036100
        • emaildeborah.langat@usamru-k.org
        • created2013-04-04 14:36:42
        • modified2020-03-02 17:38:00
    • SiteDetail(array)
      • 0(array)
        • id79
        • application_id91
        • county_id35
        • site_nameKenya Medical Research Institute Walter Reed Project Clinical Research Centre
        • physical_addressHospital Road, Kericho, Kenya
        • contact_detailsTel: +254-52 30686, P.O Box 1357 - 20200
        • contact_personDeborah C. Langat
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 14:36:42
        • modified2020-03-02 17:38:00
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id81
        • application_id91
        • county_id27
        • site_name Moi University Clinical Research Centre
        • physical_addressMoi Teaching Referral Hospital Building, Nandi Road, Eldoret, Kenya
        • contact_detailsP.O. Box 4604 - 30100 Kenya Tel:254-53 2060850
        • contact_personAbraham Mosigisi Siika
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 15:07:39
        • modified2020-03-02 17:38:00
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id45
        • application_id91
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_typeResearch Institution
        • contact_personPeter Kim
        • addressHIV Research Branch TRP, DAIDS, NIAID, NIH 6700B Rockledge Drive Bethesda, MD 20892
        • telephone_number+1-301- 451-2761
        • fax_number+1-301-480-4582
        • cell_number+1-301- 451-2761
        • email_addresskimp2@niaid.nih.gov
        • created2013-04-04 14:36:42
        • modified2020-03-02 17:38:00
  • 4(array)
    • Application(array)
      • id90
      • user_id56
      • trial_status_id5
      • abstract_of_study<p>\n 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.</p>\n<p>\n  </p>\n
      • study_title<p>\n Parallel Comparison of Tenofovir and Emtricitabine/tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples</p>\n
      • laymans_summary<p>\n 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.</p>\n
      • short_titlePARTNERS PrEP
      • protocol_noECCT/08/06/01
      • version_noVersion 3.0
      • date_of_protocol12-10-2007
      • study_drugTenofovir disoproxil fumarate (TDF), Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and matching placebo
      • 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_nameTruvada, Tenofovir and matching placebo
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameTenofovir Disoproxil Fumararte
      • comparator_registeredYES
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@rctp.or.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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • 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. Stella Njuguna
      • declaration_date104-04-2013
      • declaration_principal_investigatorDr. Elizabeth Bukusi
      • declaration_date204-04-2013
      • placebo_presentYes
      • study_objectives<p>\n • To determine if once-daily, oral PrEP with TDF or FTC/TDF provides additional protective benefit in preventing HIV-1 acquisition among HIV-1 uninfected persons within heterosexual HIV-1 discordant couples who are also receiving standard prevention interventions</p>\n<p>\n . • To assess the safety of daily PrEP using TDF or FTC/TDF by comparing rates of adverse events (AEs) among HIV-1 uninfected individuals randomized to TDF or FTC/TDF PrEP to those randomized to placebo.</p>\n
      • principal_inclusion_criteria<p>\n <strong>Partner (HIV-1 Uninfected) Participants</strong><br />\n <strong> Inclusion Criteria</strong><br />\n Potential partner (HIV-1 uninfected) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study:<br />\n • Of legal age to provide independent informed consent for research per local regulations and guidelines<br />\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 • 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:<br />\n •<br />\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)<br />\n •plan to remain in the relationship for the duration of the study period.<br />\n HIV-1 uninfected based on parallel negative HIV-1 rapid tests, both at study screening and at the enrollment visit<br />\n •Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures<br />\n •Adequate renal function, defined by creatinine clearance ≥ 60 ml/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<br />\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<br />\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>\n Not infected with HBV, as determined by a negative hepatitis B surface antigen test</p>\n<p>\n <strong>Index (HIV-1 Infected) Participants</strong></p>\n<p>\n Of legal age to provide independent informed consent for research per local regulations and guidelines.<br />\n • Able and willing to provide written informed consent to be screened for and to take part in the study.</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:<br />\n •<br />\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)<br />\n •<br />\n plan to remain in the relationship for the study period<br />\n Each study site will develop appropriate criteria for determining whether a couple is likely to remain in the relationship (i.e., married, duration of partnership, cohabitation, have children).<br />\n •<br />\n HIV-1 infected based on positive EIA.<br />\n •<br />\n CD4 cell count ≥250 cells/mm3 and not otherwise meeting national guidelines for initiation of antiretroviral therapy.<br />\n •<br />\n No history of any clinical AIDS-defining diagnoses.<br />\n •<br />\n Able and willing to provide adequate locator information for study retention purposes, as defined by loc</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong>HIV infected partner</strong></p>\n<p>\n Current use of antiretroviral therapy<br />\n •<br />\n Currently enrolled in another HIV-1 treatment trial<br />\n •<br />\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</p>\n<p>\n <strong>HIV uninfected Partner</strong></p>\n<p>\n Current pregnancy, or planning to become pregnant during the study period<br />\n •<br />\n Current breastfeeding</p>\n<p>\n Must not be currently enrolled in another HIV-1 vaccine or prevention trial.<br />\n •<br />\n Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period.<br />\n •<br />\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.<br />\n •<br />\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.History of pathological bone fractures not related to trauma<br />\n •<br />\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<br />\n •<br />\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</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • primary_end_points<p>\n HIV-1 seroconversion and AEs among HIV-1 uninfected partners</p>\n
      • scope_diagnosis1
      • 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<p>\n The Research, Care Training, and Program (RCTP) was established by leading medical researchers from the Kenya Medical Research Institute (KEMRI), the University of Nairobi (UoN) and University of California San Francisco (UCSF) in 1994 to facilitate collaborative research on STIs including HIV prevention, care and treatment. RCTP is currently co-headed by Drs. Elizabeth Bukusi (Deputy Director Research and Training, KEMRI) and Craig Cohen (Associate Professor of Medicine, UCSF). RCTP has three complementary arms namely: research, care and training. the project has a wealth of expertise in research.</p>\n<p>\n The research arm of RCTP currently has several projects on-going, which include: female microbicide studies funded by International Partnership for Microbicide (IPM), a male microbicide study funded by Consortium for National Health Research (CNHR), a pre-exposure prophylaxis study funded by Bill and Melinda Gates Foundation, as well as ANC/HIV and FP/HIV integration studies.</p>\n<p>\n Site Principal Investigator- Dr. Elizabeth Bukusi (MBChB, MMED,MPH,PHD)</p>\n<p>\n Study Cordinator- Josephine Odoyo (RN,MPH)</p>\n<p>\n Laboratory Manager- Raphael Ondondo (Msc)</p>\n<p>\n Data Manager- Bernard Rono (BSc -Statistics)</p>\n<p>\n Clinical Manager- Imeldah Wakhungu (dip Clinical Medicine)</p>\n<p>\n Pharmacy Manager- Dr. Angeline Achoka (BPharm)</p>\n<p>\n Finance and Administrative Manager- Alfred Obiero (MBA)</p>\n<p>\n QA/QC Manager- Jackson Achando (BSc Nursing, MA-Project Development)</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n 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.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI ERC- 9th May 2008, apporved the Kisumu Site study</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Efficacy was realised and the participants on Placebo were randomised to either Truvada or Tenofovir. This was a directive from the Data Safety and Monitoring Board of the PrEP study in July 2011.</p>\n
      • estimated_duration4 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_otherNo
      • design_controlled_specify
      • design_controlled_comparatormatched placebo
      • design_controlled_other_medicinalNo
      • 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_listUganda
      • data_monitoring_committeeYes
      • total_enrolment_per_site500-800 couples from each participating study site. In Kenya, there are four study sites- Kisumu, Thika, Eldoret and Nairobi
      • total_participants_worldwide3900 HIV -1 discordant couples
      • 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_male1
      • subjects_healthyNo
      • 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_nameConnie
      • investigator1_middle_name
      • investigator1_family_nameCelum
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressUniversity of Washington Box 359927 Cabrini Medical Tower, Suite 1300 901 Boren Avenue Seattle, Washington 98104
      • investigator1_telephone(206) 520-3825
      • investigator1_emailccelum@uw.edu
      • organisations_transferred_No
      • number_participants500-800 couples from each participating study site. In Kenya, there are four study sites- Kisumu, Thika, Eldoret and Nairobi
      • notification
      • approval_date30-07-2008
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-06-2020
      • 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)
      • modified2020-06-23 10:03:43
      • created2013-04-04 12:23:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id56
        • application_id90
        • given_nameElizabeth Anne
        • middle_name
        • family_nameBukusi
        • qualificationMBChB, MMed, MPH, PhD
        • professional_addressLumumba Health Center Kisumu, 614-40100 Kenya
        • telephone0733617503
        • emailebukusi@rctp.or.ke
        • created2013-04-04 12:25:31
        • modified2020-06-23 10:03:43
    • SiteDetail(array)
      • 0(array)
        • id74
        • application_id90
        • county_id42
        • site_nameKisumu site
        • physical_addressLumumba Health Centre
        • contact_details614-40100 0733617503
        • contact_personDr. Elizabeth Bukusi
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 12:25:31
        • modified2020-06-23 10:03:43
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id42
        • application_id90
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_person
        • addressUniversity of Washington Box 359927 Cabrini Medical Tower, Suite 1300 901 Boren Avenue Seattle, Washington 98104
        • telephone_number (206) 520-3825
        • fax_number(206) 520-3831
        • cell_number (206) 520-3825
        • email_addressccelum@u.washington.edu
        • created2013-04-04 12:25:31
        • modified2020-06-23 10:03:43
• 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