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  • approved1

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• trial_statuses(array)
  • 1Recruiting
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• applications(array)
  • 0(array)
    • Application(array)
      • id820
      • user_id43
      • trial_status_id7
      • abstract_of_study<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:624px;\" width=\"0\">\n <tbody>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Phase of Study:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <p>\n Phase II</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Participating Institutions:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <p>\n This protocol will be open to all AMC international member sites in sub-Saharan Africa. Participating institutions will also be required to complete Celgene’s pregnancy prevention counseling training before activating this trial.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Accrual Target:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <p>\n 30 participants</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Population:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <p>\n Participants with KS and HIV infection.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Regimen:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <p>\n Each cycle of treatment includes administration of 21 doses of pomalidomide during a 4-week period, administered on Days 1-21 of a 28-day cycle.</p>\n <p>\n Eligible participants will begin pomalidomide therapy at Dose Level 1, 4 mg/day on Days 1-21 of each 28-day cycle.</p>\n <p>\n Dose level -1, 3 mg/day on Days 1-21 of each 28-day cycle, is provided for participants entered on Dose Level 1 who require dose reduction.</p>\n <p>\n Safety and the need for dose reduction will be continuously monitored by the protocol team.</p>\n <p>\n Antitumor effects will be assessed immediately prior to the start of each 28-day treatment cycle in all participants and every 12 weeks after completion of pomalidomide therapy in participants showing complete or partial response.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Duration:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <p>\n The maximum duration of treatment is 12, 4-week cycles.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Primary Objective:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <p>\n To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated KS in sub-Saharan Africa and is safe and tolerable.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Secondary Objectives:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <p>\n To evaluate the effects of pomalidomide monotherapy on standard measures of HIV control, i.e., CD4 counts and HIV viral loads, in this participant population.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:199px;\">\n <p>\n <strong>Exploratory Objectives:</strong></p>\n </td>\n <td style=\"width:444px;\">\n <ol>\n <li>\n To assess the effect of pomalidomide treatment on serum cytokine levels.</li>\n <li>\n To evaluate if changes in serum cytokine levels correlate with clinical response.</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals with Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)</strong></p>\n
      • laymans_summary<p>\n This is a Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals with Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA). The study objective is to determine if pomalidomide monotherapy induces an antitumor efficacy and whether it is safe and tolerable, in order to justify its further development for treatment of HIV-associated KS in sub-Saharan Africa.</p>\n
      • short_titleAMC-100
      • protocol_noECCT/19/10/02
      • version_no5
      • date_of_protocol07-05-2019
      • study_drugPomalidomide
      • disease_conditionKaposis Sarcoma
      • 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_namePomalidomide
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamckenya@yahoo.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_countries1
      • 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_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. EVANGELINE NJIRU
      • declaration_date123-08-2019
      • declaration_principal_investigatorDR. NAFTALI BUSAKHALA
      • declaration_date223-08-2019
      • placebo_presentNo
      • study_objectives<p>\n Primary Objective</p>\n<p>\n To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy to justify its further development for HIV-associated KS in sub-Saharan Africa and is safe and tolerable.</p>\n<p>\n Secondary Objective</p>\n<ol>\n <li>\n To evaluate the effects of pomalidomide monotherapy on CD4 counts and HIV viral loads in this participant population.</li>\n <li>\n To assess the effect of pomalidomide treatment on serum cytokine levels.</li>\n <li>\n To evaluate if changes in serum cytokine levels correlate with clinical response.</li>\n</ol>\n
      • principal_inclusion_criteria<h2>\n Eligibility Criteria</h2>\n<ol>\n <li>\n Participants must have measurable cutaneous KS that has been pathologically confirmed by an AMC-approved pathologist.</li>\n <li>\n Participants may not show evidence for ongoing improvement in KS lesions in the 4 weeks prior to enrollment.</li>\n <li>\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.</li>\n <li>\n Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of Pomalidomide in participants <18 years of age, children are excluded from this study.</li>\n <li>\n Eastern Cooperative Oncology Group (ECOG) performance status <u><</u> 2 (Karnofsky Performance Status (KPS) <u>></u> 50.</li>\n <li>\n Life expectancy ≥ 12 weeks.</li>\n <li>\n Participants must have organ and marrow function within the following parameters, unsupported by hematopoietic growth factors within 7 days prior to enrollment:</li>\n</ol>\n<ul>\n <li>\n Hemoglobin ≥ 8 g/dL</li>\n <li>\n Absolute neutrophil count (ANC): ≥ 1,000 cells/mm³ (1.0 x 10⁹/L)</li>\n <li>\n Platelets: ≥ 75,000 cells/mm³ (75.0 x 10⁹/L)</li>\n <li>\n Total bilirubin: £ 1.5 times the upper limit of normal (ULN), unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be £ 2 times the ULN.</li>\n <li>\n Serum AST (SGOT) / ALT (SGPT): £ 2.5 x ULN</li>\n <li>\n Estimated or measured creatinine clearance ≥ 60 mL/minute (1.00 mL/s) (serum creatinine £ 2.0 mg/dL / 176.8 mmol/L)</li>\n</ul>\n<p>\n         8. Currently receiving local standard of care ART for ≥ 12 weeks, with HIV viral load ≤ 400 copies/mL within the preceding 12 weeks prior to enrollment.</p>\n<p>\n             Participants are required to be on antiretroviral regimens that are in accordance with the current International AIDS Society guidelines concurrently with    chemotherapy. Excepting agents containing zidovudine, which is prohibited, the specific agents are at the discretion of the Investigator and the use of investigational ART agents currently available on an expanded access basis is allowed.</p>\n<p>\n        9.  A FCBP is a female who has achieved menarche at some point, is < 60 years of age, and who meets one of the following criteria:</p>\n<p>\n             i) has not undergone a hysterectomy or bilateral oophorectomy, or</p>\n<p>\n             ii) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months     (i.e.,         has had menses at any time in the preceding 24 consecutive months), or</p>\n<p>\n             iii) does not have a serum or plasma FSH >40 mIU/mL and a history of amenorrhea x ≥ 1 year</p>\n<p>\n FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to enrollment and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or, if complete abstinence cannot be assured, they must begin TWO acceptable methods of birth control, including one of the following highly effective, long-acting methods, DepoProvera, an intrauterine device (IUD), an implant*, or bilateral tubal ligation, if it can be verified that the procedure was performed, and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing.</p>\n<p style=\"margin-left:81.0pt;\">\n <strong>* NOTE:</strong> Implants containing levonorgestrel and etonogestrel are prohibited in women receiving efavirenz, as drug interactions will render the implants ineffective.</p>\n<p>\n Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy.</p>\n<p>\n All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Serum or urine pregnancy testing will be repeated in FCBP, and must be negative, within 24 hours of starting each new cycle of pomalidomide.</p>\n<p>\n 10. Able to take aspirin (≥ 75 mg) daily as prophylactic anticoagulation.</p>\n<p>\n 11.  Ability to understand and the willingness to sign a written informed consent document.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<h2>\n Exclusion Criteria</h2>\n<p>\n 1.         Participants who are receiving any other investigational agents (except as permitted by the study).</p>\n<p>\n 2.         Any prior use of thalidomide, lenalidomide, or pomalidomide.</p>\n<p>\n 3.         History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide.</p>\n<p>\n 4.         Participants who have visceral disease requiring cytotoxic chemotherapy (i.e., pulmonary KS, symptomatic gastrointestinal KS). KS-related lymphedema is permitted.</p>\n<p>\n 5.         Use of agents containing zidovudine (including Combivir^® and Trizivir^®) are prohibited. In order to be eligible, participants taking zidovudine must change to a different regimen at least 7 days prior to therapy initiation. Changes to ART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.).</p>\n<p>\n Use of medications or substances that are strong inhibitors of CYP1A2, which include amiodarone, cimetidine, fluoroquinolones (e.g., ciprofloxacin, enoxacin), fluvoxamine, and ticlopidine is prohibited.</p>\n<p>\n Co-administration of efavirenz, an inhibitor of CYP1A2, with strong inhibitors of CYP3A4 and P-glycoprotein (P-gp) is prohibited. Use of erythropoietin is prohibited.</p>\n<p>\n Co-administration of corticosteroids greater than doses required for treatment of adrenal insufficiency is prohibited.</p>\n<p>\n Because the lists of these agents are constantly changing, it is important to regularly consult frequently updated medical references.</p>\n<p>\n 6.         Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection for which the participant has not completed at least 14 days of therapy prior to study enrollment and/or is not clinically stable; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.</p>\n<p style=\"margin-left:1.0in;\">\n 7.         Pregnant women are excluded from this study because pomalidomide is a thalidomide analogue with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pomalidomide, breastfeeding should be discontinued if the mother is treated with pomalidomide.</p>\n<p>\n 8.         Specific KS therapy, including cytotoxic chemotherapy but not including ART, within the past 4 weeks.</p>\n<p>\n 9.         Use of other anticancer treatments or agents within the past 4 weeks.</p>\n<p>\n 10.       History of malignant tumors other than KS, unless:</p>\n<ul>\n <li>\n In complete remission for ≥ 1 year, or</li>\n <li>\n Completely resected basal cell carcinoma, or</li>\n <li>\n In situ squamous cell carcinoma of the cervix or anus.</li>\n</ul>\n<p>\n 11.       Grade ≥ 3 peripheral neuropathy.</p>\n<p>\n 12.       History of myocardial infarction (MI), cerebrovascular accident, or venous or arterial thromboembolism, unless line-related thrombosis without embolus occurring greater than 1 year prior to study entry.</p>\n<p>\n 13.       Known procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.</p>\n<p>\n 14.       Any condition, including the presence of current laboratory abnormalities or other factor that, in the opinion of the investigator, places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.</p>\n<p>\n  </p>\n
      • primary_end_points<ul>\n <li>\n Overall response rate</li>\n <li>\n Complete response rate</li>\n <li>\n Proportion of participants who experience toxicities of grade 3 or higher</li>\n</ul>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin-left:5.2pt;\">\n <u>S</u><u>taff</u></p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Naftali Busakhala MBChB, MMed, Principal Investigator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Evangeline W. Njiru- MBChB, MMed- Investigator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Gabriel Kigen, B Pharm, Pharmacist of Record</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Job Kisuya, PhD - Site Coordinator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Seth Kirui, Bsc - Data Manager</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Joyce Musimbi, Bsc - Research Assistant</p>\n<p style=\"margin-left:5.2pt;\">\n  </p>\n<p style=\"margin-left:5.2pt;\">\n David Oduori - Recruitment Officer</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Simon Wachira, B Pharm- Back-up Pharmacist</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Fred Kiplagat, Dip Pharm- Back-up Pharmaceutical Technologist</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n <u>S</u><u>ite/Emergency Facilities:</u></p>\n<p>\n  </p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Program– Has 24 care sites and 34 satellite clinics in North Rift and Western</p>\n<p style=\"margin-left:41.2pt;\">\n Kenya</p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Oncology Clinic-Has 1 care site and 4 satellite clinics in North Rift and</p>\n<p style=\"margin-left:41.2pt;\">\n Western</p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Reference Laboratory and MTRH histopathology Laboratory</p>\n<p style=\"margin-left:23.2pt;\">\n ·    Moi Teaching and Referral Hospital (MTRH)- Second largest referral Hospital in Kenya.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Eldoret, Kenya is one of the Africa AMC sites. When protocols are developed by the AMC, sites express interests considering the patient population and relevance of the study. Our site expressed interest and was chosen as a participating site.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n AUTHORITY: MOI UNIVERSITY INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE</p>\n<p>\n DATE OF APPROVAL : 2019</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration60 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMOI UNIVERSITY CLINICAL RESEARCH CENTER
      • single_site_physical_addressCHANDARIA CANCER AND CHRONIC DISEASE CENTRE, NANDI ROAD
      • single_site_contact_personDR. NAFTALI BUSAKHALA
      • single_site_telephone0722496933
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites
      • multi_country_listKENYA: MOI UNIVERSITY CLINICAL RESEARCH CENTER UGANDA: UGANDA CANCER INSTITUTE ZIMBABWE: UNIVERSITY OF ZIMBABWE SOUTH AFRICA: WITWATERSRAND UNIVERSITY, TANZANIA: BUGANDO MEDICAL CENTER, MALAWI: UNC PROJECT
      • data_monitoring_committeeNo
      • total_enrolment_per_site10
      • total_participants_worldwide30
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameEVANGELINE
      • investigator1_middle_name
      • investigator1_family_nameNJIRU
      • investigator1_qualificationMBCHB, MMED
      • investigator1_professional_address4606
      • investigator1_telephone0722624353
      • investigator1_emailoyungueva@yahoo.com
      • organisations_transferred_No
      • number_participants10
      • notification
      • approval_date01-04-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-07-18 10:41:25
      • created2019-08-23 16:45:54
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id509
        • application_id820
        • given_nameNAFTALI
        • middle_nameWISINDI
        • family_nameBUSAKHALA
        • qualificationMBCHB, MMED
        • professional_address4606
        • telephone0722496933
        • emailnbusakhala@yahoo.com
        • created2019-08-23 20:41:18
        • modified2020-03-05 10:07:02
    • SiteDetail(array)
      • 0(array)
        • id666
        • application_id820
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-08-23 20:41:18
        • modified2020-03-05 10:07:02
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id397
        • application_id820
        • sponsorNational Cancer Institute Office of HIV and AIDS Malignancy (OHAM)
        • sponsor_typeOthers
        • contact_person
        • address31 Center Drive, Room 3A33 Bethesda, MD, USA 20852-2440
        • telephone_number301-496-4995
        • fax_number
        • cell_number301-496-4995
        • email_addressNCIOHAMContact@mail.nih.gov
        • created2019-08-23 20:41:18
        • modified2020-03-05 10:07:02
  • 1(array)
    • Application(array)
      • id821
      • user_id43
      • trial_status_id9
      • abstract_of_study<p>\n <strong> Broad Objectives: </strong></p>\n<p>\n To determine if HPV vaccination reduces the occurrence of cervical HSIL among HIV-infected women participating in anHPV test-and-treat strategy for cervical cancer prevention.</p>\n<p>\n <strong>Specific Objectives:</strong><br />\n •To describe occurrence of cervical HSIL from week 52 to</p>\n<p>\n week 104.</p>\n<p>\n •To examine the predictors of sustained absence of cervical HSIL through week 104 and clearance of HPV infections after cervical treatment,including: baseline types and quantity of HPV, presence of HSIL at baseline, cryotherapy vs. LEEP, CD4+ cell count, plasma HIV-1 RNA,ART use, age, sexual behavior, and vaccination use.</p>\n<p>\n •To compare, between study arms, incident cervical vaccine type HPV infections and cervical cytology results.</p>\n<p>\n •To describe prevalent and incident vulvar HSIL or cancer in this population.</p>\n<p>\n  </p>\n<p>\n <strong>Study setting: </strong>[  MTRH Chandaria Cancer and Chronic Disease Centre, Cervical Cancer Screening Clinic]</p>\n<p>\n <strong>Study population: </strong>[HIV-infected females 25 and older, currently receiving antiretroviral therapy for at least 6 months with no prior history of cervical, vulvar, or vaginal cancer.</p>\n<p>\n <strong>Number of subjects to be contacted: </strong></p>\n<p>\n 536 participants</p>\n<p style=\"margin-left:-21.3pt;\">\n <strong>Stu  Study procedures (main) done on participants: </strong></p>\n<p>\n Potential participants will be tested for cervical human papillomavirus</p>\n<p>\n (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy. If eligible, the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo.</p>\n<p>\n Participants will return 4 and 26 weeks later to complete the vaccination (or placebo) series. At week 4, participants will have cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical Cryotherapy will have cervical biopsies obtained just prior to the treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at week 26, 52, 78, and 104, as well as with cytology and cervical colposcopy with biopsies at week 26, 52,and 104</p>\n
      • study_title<p>\n A Randomized, Placebo-Controlled Trial of HPV Vaccination to Reduce Cervical High-Grade Squamous Intraepithelial Lesions among HIV-Infected Women Participating in an HPV Test-and-Treat Program (COVENANT)</p>\n
      • laymans_summary<p>\n HIV-infected females 25 and older, currently receiving antiretroviral therapy for at least 6 months with no prior history</p>\n<p>\n of cervical, vulvar, or vaginal cancer. Participants must be HPV-positive by GeneXpert hrHPV assay with HPV16, 18/45, or 31/33/35/52/58 detected. Participants must not have had a hysterectomy, prior treatment for cervical HSIL or prior HPV vaccination.</p>\n<p>\n <strong>Regimen:</strong></p>\n<p>\n Potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXperthrHPV assay and HPV DNA PCR)</p>\n<p>\n and undergo cervical colposcopy. If eligible the participant will be randomized to receive either the 9-valent HPV vaccine or saline</p>\n<p>\n placebo. Participants will return 4 and 26 weeks later to complete the vaccination (or placebo) series.At week 4, participants will have</p>\n<p>\n cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate.</p>\n<p>\n Participants undergoing cervical cryotherapy will have cervical biopsies obtained just prior to the</p>\n<p>\n treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at week 26, 52, 78, and 104, as well</p>\n<p>\n as with cytology and cervical colposcopy with biopsies at week 26, 52, and 104.</p>\n
      • short_titleAMC-099
      • protocol_noECCT/19/10/01
      • version_noVersion 3
      • date_of_protocol01-08-2018
      • study_drugGardasil 9
      • disease_conditionCervical Cancer
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamckenya@yahoo.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_countries1
      • 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_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. OMENGE ORANGO
      • declaration_date123-08-2019
      • declaration_principal_investigatorDR. NAFTALI BUSAKHALA
      • declaration_date223-08-2019
      • placebo_presentYes
      • study_objectives<div>\n Primary Objective</div>\n<div>\n <ol>\n <li>\n To determine if HPV vaccination reduces the occurrence of cervical HSIL among HIV-infected women participating in an HPV test-and-treat strategy for cervical cancer prevention.</li>\n </ol>\n</div>\n<div>\n Secondary Objectives</div>\n<ol>\n <li>\n To describe occurrence of cervical HSIL from week 52 to week 104.</li>\n <li>\n To examine the predictors of sustained absence of cervical HSIL through week 104 and clearance of HPV infections after cervical treatment, including: baseline types and quantity of HPV, presence of HSIL at baseline, cryotherapy vs. LEEP, CD4+ cell count, plasma HIV-1 RNA, ART use,age, sexual behavior, and vaccination use.</li>\n <li>\n To compare, between study arms, incident cervical vaccine type HPV infections and cervical cytology results.</li>\n <li>\n To describe prevalent and incident vulvar HSIL or cancer inthis population.</li>\n</ol>\n
      • principal_inclusion_criteria<ol>\n <li>\n HIV-1 infection</li>\n <li>\n <p>\n HPV positive by the GeneXpert hrHPV assay with HPV16, HPV 18/45, or HPV31/33/35/52/58 detected. <u>Note</u>: Participants who are hrHPV positive with only HPV51/59 or HPV 39/68/56/66 detected are not eligible.</p>\n </li>\n <li>\n <p>\n Age ≥ 25 years.</p>\n </li>\n <li>\n <p>\n Receipt of ART for at least 180 days prior to randomization.</p>\n </li>\n <li>\n <p class=\"Level3Heading\">\n Participants of childbearing potential, defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonal contraception), delaying pregnancy for at least 12 months and ideally for the duration of the study.</p>\n </li>\n <li>\n <p class=\"Level3Heading\">\n <o:p>If the participant is of childbearing potential, she should be at least 3 months postpartum.</o:p></p>\n </li>\n <li>\n <p class=\"Level3Heading\">\n Karnofsky score <u>></u>70%.</p>\n </li>\n <li>\n <p>\n  </p>\n <p class=\"Level3Heading\">\n  Ability to understand and the willingness to sign a written informed consent document.</p>\n <p class=\"Level3Heading\">\n  </p>\n <br />\n  </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Current STI requiring treatment (women may participate after adequate treatment, at the discretion of the treating provider).</li>\n <li>\n History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gardasil or Gardasil 9.</li>\n <li>\n Uncontrolled intercurrent illness that would limit compliance with study requirements.</li>\n <li>\n Prior hysterectomy with removal of the cervix.</li>\n <li>\n Prior treatment for cervical HSIL.</li>\n <li>\n Prior history of cervical, vulvar, or vaginal cancer.</li>\n <li>\n Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless biopsies show no invasive cancer.</li>\n <li>\n Known bleeding diathesis.</li>\n <li>\n Prior HPV vaccination</li>\n <li>\n Current or planned use of anticoagulants other than aspirin or non-steroidal anti-inflammatory agents.</li>\n <li>\n Documentation of WHO Clinical Stage 3 or 4 condition within 6 months of entry.</li>\n <li>\n CD4 count <200 cells/mm³ within 6 months of entry.</li>\n</ol>\n
      • primary_end_points<p class=\"Bodytextlevel3\">\n Cervical HSIL or invasive cervical cancer diagnosed after the week 4 visit through week 52 post-randomization.<o:p></o:p></p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • 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 style=\"margin-left:5.2pt;\">\n <u>S</u><u>taff</u></p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Naftali Busakhala MBChB, MMed, Site Investigator</p>\n<p style=\"margin-left:5.2pt;\">\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Dr. Omenge Orango, MBChB, MMed, Prinicipal Investigator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Peter Itsura - MBChB, MMed- Investigator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Gabriel Kigen, B Pharm, Pharmacist of Record</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Job Kisuya, PhD - Site Coordinator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Seth Kirui, Bsc - Data Manager</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Joyce Musimbi, Bsc - Research Assistant</p>\n<p style=\"margin-left:5.2pt;\">\n  </p>\n<p style=\"margin-left:5.2pt;\">\n David Oduori - Recruitment Officer</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Simon Wachira, B Pharm- Back-up Pharmacist</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Fred Kiplagat, Dip Pharm- Back-up Pharmaceutical Technologist</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n <u>S</u><u>ite/Emergency Facilities:</u></p>\n<p>\n  </p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Program– Has 24 care sites and 34 satellite clinics in North Rift and Western</p>\n<p style=\"margin-left:41.2pt;\">\n Kenya</p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Oncology Clinic-Has 1 care site and 4 satellite clinics in North Rift and</p>\n<p style=\"margin-left:41.2pt;\">\n Western</p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Reference Laboratory and MTRH histopathology Laboratory</p>\n<p style=\"margin-left:23.2pt;\">\n ·    Moi Teaching and Referral Hospital (MTRH)- Second largest referral Hospital in Kenya.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Eldoret, Kenya is one of the Africa AMC sites. When protocols are developed by the AMC, sites express interests considering the patient population and relevance of the study. Our site expressed interest and was chosen as a participating site.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n AUTHORITY: MOI UNIVERSITY INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE</p>\n<p>\n DATE OF APPROVAL : 2019</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration48
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorGardasil 9 vaccine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMOI UNIVERSITY CLINICAL RESEARCH CENTER
      • single_site_physical_addressCHANDARIA CANCER AND CHRONIC DISEASE CENTRE, NANDI ROAD
      • single_site_contact_personDR. NAFTALI BUSAKHALA
      • single_site_telephone0722496933
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites
      • multi_country_listKENYA: MOI UNIVERSITY CLINICAL RESEARCH CENTER UGANDA: UGANDA CANCER INSTITUTE ZIMBABWE: UNIVERSITY OF ZIMBABWE SOUTH AFRICA: WITWATERSRAND UNIVERSITY, TANZANIA: BUGANDO MEDICAL CENTER, MALAWI: UNC PROJECT
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide536
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_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_nameNAFTALI
      • investigator1_middle_nameWISINDI
      • investigator1_family_nameBUSAKHALA
      • investigator1_qualificationMBCHB, MMED
      • investigator1_professional_address4606
      • investigator1_telephone0722496933
      • investigator1_emailnbusakahala@yahoo.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date01-04-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy Approved
      • final_report<p>\n A Randomized, Placebo-Controlled Trial of HPV Vaccination to Reduce Cervical High-Grade Squamous Intraepithelial Lesions among HIV-Infected Women Participating in an HPV Test-and-Treat Program (COVENANT). </p>\n<p>\n HIV-infected females 25 and older, currently receiving antiretroviral therapy for at least 6 months with no prior history of cervical, vulvar, or vaginal cancer. Participants must be HPV-positive by GeneXpert hrHPV assay with HPV16, 18/45, or 31/33/35/52/58 detected. Participants must not have had a hysterectomy, prior treatment for cervical HSIL or prior HPV vaccination.</p>\n<p>\n Potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy. If eligible, the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo. Participants will return 4 and 26 weeks later to complete the vaccination (or placebo) series. At week 4, participants will have HPV testing, cervical colposcopy, and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical cryotherapy will have cervical biopsies obtained just prior to the treatment. Participants will be followed with HPV testing (GeneXpert and HPV DNA PCR) at week 26, 52, 78, and 104, as well as with cytology and cervical colposcopy with biopsies at week 26, 52, and 104.</p>\n
      • implication_results<p>\n Not applicable because Moi site will not participate in the study and therefore we are requesting for witdrawal from activation of ECCT/19/10/01 ( AMC-099).</p>\n
      • quantity_importedNone
      • quantity_dispensedNone
      • quantity_destroyedNone
      • quantity_exportedNone
      • balance_siteNone
      • final_date0000-00-00
      • modified2024-06-04 14:23:27
      • created2019-08-23 16:50:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id508
        • application_id821
        • given_nameELKANAH
        • middle_nameORANGO
        • family_nameOMENGE
        • qualificationMBCHB, MMED
        • professional_address4606
        • telephone0722609132
        • emailbworango2000@yahoo.com
        • created2019-08-23 20:40:16
        • modified2020-03-05 10:20:05
    • SiteDetail(array)
      • 0(array)
        • id665
        • application_id821
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-08-23 20:40:16
        • modified2020-03-05 10:20:05
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id396
        • application_id821
        • sponsorNational Cancer Institute Office of HIV and AIDS Malignancy (OHAM)
        • sponsor_typeOthers
        • contact_person
        • address31 Center Drive, Room 3A33 Bethesda, MD, USA 20852-2440
        • telephone_number301-496-4995
        • fax_number
        • cell_number301-496-4995
        • email_addressNCIOHAMContact@mail.nih.gov
        • created2019-08-23 20:40:16
        • modified2020-03-05 10:20:05
  • 2(array)
    • Application(array)
      • id789
      • user_id522
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background</strong>: Induction of labor (IOL) has increasingly become a common procedure, more so in developed countries where the incidence currently averages 20-30%. In developing countries, IOL is variable ranging from 2% to as high as that seen in developed nations. In MTRH, about 5% of all deliveries are term inductions. Nulliparous women often comprise over half of those requiring IOL even in our setting. Additionally, the presence of an unfavorable cervix prior to induction is not uncommon in this group and is often associated with failed inductions, labor dystocia, caesarean sections and longer hospital stays. Hence the need for preinduction cervical ripening using a safe, efficient and cost effective method. This optimal method is not known. Recently, the concurrent use of Foley catheter (FC) with oxytocin for cervical ripening has been studied albeit in primarily Caucasian population. The findings have nonetheless been mixed.</p>\n<p>\n <strong>Objective</strong>: To determine whether adding low dose oxytocin to preinduction cervical ripening with a FC affects the time to delivery, proportion of deliveries within 24 hours and fetomaternal outcomes in nulliparous women at MTRH.</p>\n<p>\n <strong>Methods</strong>: This is a randomized double blind placebo controlled trial to be conducted at the Riley Mother and Baby hospital in MTRH. 220 nulliparous women aged at least 18 years with a single, live, vertex pregnancy and scheduled for IOL with an unfavorable cervix at or beyond 34 weeks gestation will be systematically sampled for inclusion in the study. Consenting participants will be allocated to receive FC plus low dose oxytocin or FC plus placebo using block randomisation, with a block size of 20. The primary and secondary endpoints will be at delivery and 24 hours post-delivery respectively. Data will be collected using semi-structured data collection forms and entered into an electronic database using Microsoft Access. Categorical variables will be summarized using frequencies and percentages. Continuous variables will be summarized using mean and the corresponding standard deviation (SD) if the Gaussian assumptions hold or using median and the corresponding inter quartile range (IQR) if the Gaussian assumptions are violated. The time to delivery will be compared between the two arms using independent t-test if the Gaussian assumptions hold or using the two sample Wilcoxon rank-sum test if the Gaussian assumptions are violated. Categorical variables will be compared between the two arms using Pearson’s Chi Square test. Linear regression model will be used to assess the effect of Foley catheter plus oxytocin adjusting for potential confounding variables. We shall report the regression coefficients and the corresponding 95% confidence intervals. Results will be presented using tables and graphs. Data analysis will be done using SAS version 9.4.</p>\n<p>\n <strong>Expected findings:</strong> The time to delivery has a potentially significant impact on resources and obstetric outcomes. Our study seeks to establish the impact of concurrent FC and oxytocin on the time to delivery and the safety of the same in nulliparous women undergoing cervical ripening in our setting. This will robustly complement previous studies and ultimately inform future protocols with rational, objective and evidence based data.</p>\n
      • study_title<p>\n LOW DOSE OXYTOCIN AS AN ADJUNCT TO FOLEY CATHETER FOR CERVICAL RIPENING IN NULLIPAROUS WOMEN AT MTRH, ELDORET, KENYA: A RANDOMISED CONTROLLED TRIAL.</p>\n
      • laymans_summary(null)
      • short_titleLOxaF- N Trial
      • protocol_noECCT/19/08/02
      • version_no1
      • date_of_protocol26-09-2018
      • study_drugOxytocin
      • disease_conditionRipening of the cervix
      • 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_nameSyntocinon
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspatrickomondi_md@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_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_applicantPatrick Omondi Otieno
      • declaration_date123-06-2019
      • declaration_principal_investigatorDr Patrick Omondi
      • declaration_date223-06-2019
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n a. Nulliparous women at or beyond 34+0 weeks gestation from the LMP b. At least 18 years old c. Single, live and vertex fetus d. Written informed consent</p>\n
      • principal_exclusion_criteria<p>\n a. Admission Bishop score > 6</p>\n<p>\n b. Sonographically confirmed anomalous fetus.</p>\n<p>\n c. Prelabor rupture of membranes (PROM)</p>\n<p>\n d. Suspected intraamniotic infection</p>\n<p>\n e. Intrauterine fetal demise</p>\n<p>\n f. Any contraindication to vaginal delivery</p>\n<p>\n g. Scarred uterus</p>\n
      • primary_end_points<p>\n Delivery of the fetus.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n MTRH is a level 6 tertiary referral health facility in Eldoret, Uasin Gishu county. The RMBH has 4 wards namely; antenatal ward (ANW), postnatal ward (PNW) and labor ward (L/W) where women in active phase of labor are admitted for monitoring and delivery. The RMBH unit is staffed by about 16 consultant obstetrician/gynecologists from both Moi University and MTRH, 46 residents/registrars and 88 nurses/midwives.</p>\n
      • other_details_explanation<p>\n Not Applicable</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n The Moi University/MTRH Institutional research and ethics commitee - 26/09/2018</p>\n<p>\n The Moi Teaching and Referral Hospital - 02/10/2018</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo (Water for inject
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThe Riley Mother and Baby Hospital (RMBH) at Moi Teaching and Referral Hospital (MTRH) in Eldoret, Kenya.
      • single_site_physical_address-
      • single_site_contact_personPatrick Omondi Otieno
      • single_site_telephone0731226249
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNot applicable
      • total_participants_worldwideNot Applicable
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameOtieno
      • investigator1_middle_nameOmondi
      • investigator1_family_namePatrick
      • investigator1_qualificationBachelor of Medicine and Bachelor of Surgery (MBchB)
      • investigator1_professional_address4606-30101, Eldoret, Uasin Gishu County, Kenya.
      • investigator1_telephone+254731226249
      • investigator1_emaildoc_omondi@yahoo.com
      • organisations_transferred_No
      • number_participants220 at Single study site
      • notification<p>\n N/A</p>\n
      • approval_date01-10-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-08-2019
      • is_child0
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      • modified2021-11-09 18:21:07
      • created2019-04-16 13:31:05
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        • id492
        • application_id789
        • given_namePatrick Omondi
        • middle_name
        • family_nameOtieno
        • qualificationMBChB
        • professional_address4606-30100
        • telephone0731226249
        • emaildoc_omondi@yahoo.com
        • created2019-04-16 13:55:47
        • modified2019-08-25 21:19:15
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        • created2019-04-16 13:55:47
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    • Sponsor(array)
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        • id384
        • application_id789
        • sponsorSelf
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        • contact_personPatrick Omondi Otieno
        • address4606-30100
        • telephone_number0731226249
        • fax_number
        • cell_number0731226249
        • email_addressdoc_omondi@yahoo.com
        • created2019-04-16 13:55:47
        • modified2019-08-25 21:19:15
  • 3(array)
    • Application(array)
      • id816
      • user_id81
      • trial_status_id4
      • abstract_of_study<p>\n Malaria is a disease of major public health importance. The only vaccine available is partially effective and targets the pre-erythrocytic stages of the life cycle. Thus, there is a need to identify other potential vaccine targets as well as to develop models to test vaccine efficacy, especially that of transmission-blocking vaccines. Controlled human malaria infection (CHMI) has been shown to be an important tool for the assessment of the efficacy of novel malaria vaccines and drugs. CHMI also allows for the evaluation of immunity to malaria and monitoring of parasite growth rates <em>in vivo</em>. This is particularly useful in individuals from endemic areas with varying levels of exposure and immunity to malaria. Thus, CHMI in individuals with prior exposure to malaria has potential to accelerate malaria vaccine development. In this study, we aim to use CHMI in semi-immune adults to develop a model to assess transmissibility of malaria infection to mosquitoes, to study immune responses that are directed against sexual stages that might block transmission, and as a platform to test vaccines. To achieve this, the study will be carried out in two phases A (N=45 participants) and B (N=60 participants) over a period of 4-6months. We will vary the parasite dose in individuals enrolled for CHMI and use low-doses of anti-malarial drugs to promote the production of gametocytes <em>in vivo</em> (Phase A) and demonstrate transmissibility in mosquito feeding assays (Phase B). Thus, the main outcomes of the study will be: (1) optimisation of sporozoite dose for infections success in individuals with moderate-high malaria exposure; (2) use of sub-curative anti-malaria treatment for induction of gametocytes; and (3) infection of mosquitoes in mosquito feeding assays by induced gametocytes. To achieve this, we will screen up to 250 semi-immune adults who will be recruited from known areas of malaria endemicity in Kenya with varying exposure to malaria and enrol 105 individuals to conduct CHMI studies with serial quantitative polymerase chain reaction (PCR) to measure asexual parasite growth and induction of transmission stages <em>in vivo</em>. In addition, we will comprehensively characterize immunity and identify targets in relation to function assessed by various laboratory assays.</p>\n
      • study_title<p>\n Safety and feasibility of a malaria transmission model in semi-immune Kenyan adults using <em>Plasmodium falciparum</em> sporozoites</p>\n
      • laymans_summary<address>\n <strong>Formal Title: </strong>Safety and feasibility of a malaria transmission model in semi-immune Kenyan adults using <em>Plasmodium falciparum</em> sporozoites</address>\n<address>\n <strong>Lay Title: </strong>Use of malaria infection by injection to study malaria transmission</address>\n<address>\n <strong>What is the problem/background?</strong></address>\n<p>\n Malaria remains a major public health problem with up to half a billion-people infected with the parasite that causes the disease. In recent and ongoing studies, we have conducted controlled malaria infection in 189 Kenyan adults. By measuring malaria parasites in the blood, we have gained insights into the growth of parasites that will guide vaccine development. One other approach to vaccination is to target the transmitting stages of the malaria parasites such that mosquitoes feeding on the infected person would not become infected, thus breaking the life cycle of the parasite. There is a need to develop experimental methods to test the effect of candidate vaccines designed to interrupt transmission to mosquitoes so that vaccines showing evidence of efficacy can then be prioritized for large trials in the field. Furthermore, studying natural immunity in humans to the stages involved in malaria transmission will help characterize potential targets for new vaccines. </p>\n<address>\n <strong>What questions are we trying to answer?</strong></address>\n<p>\n We wish to develop a method to test the efficacy of vaccines and/or drugs designed to block transmission of malaria to mosquitoes and to identify the targets of transmission-blocking immunity to malaria.</p>\n<address>\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></address>\n<p>\n The study will take place in Kilifi, Kenya. The study will involve the recruitment and screening of up to 250 individuals from Ahero and Kilifi to determine eligibility for participation and past exposure to malaria. This will be done after a programme of sensitisation and information giving about the study. The study will be conducted in two phases where individuals with moderate to high malaria exposure will be enrolled to participate in the following:</p>\n<ol>\n <li>\n Phase A (N = 45): “dose-finding” of the dose of sporozoites given and optimisation of the dose of anti-malarial drug that will be used to promote development of transmission stages without clearing the infection completely (i.e. a “sub-curative dose”);</li>\n <li>\n Phase B (N = 60): assessing infectivity of induced malaria transmission stages to mosquitoes.</li>\n</ol>\n<p>\n For each of these phases, selection will be based on level of past malaria exposure and health status. To determine these, blood samples will be taken at the point of screening for each individual participant.</p>\n<address>\n <strong>What does the study involve for those who are in it?</strong></address>\n<p>\n For screening, a blood sample of 21ml will be collected at the time of recruitment. A urine sample and medical history will also be obtained in addition to undergoing a clinical assessment and a test to check the functioning of the heart. For enrollment, a participant will need to have moderate to high malaria exposure and have no clinical disease. Those that meet this criteria, some will be enrolled into phase A and some into phase B (phase A will happen before phase B) for malaria infection studies and be required to stay at an in-patient facility in Kilifi near KEMRI-Kilifi. The participants will be asked to stay at the facility throughout the study so that they are closely monitored by the study staff. To transmit malaria to mosquitoes the human challenge model must first reliably induce infection and of a sufficient duration before being able to develop transmitting stages. We will:</p>\n<ol>\n <li>\n For Phase A: Assign individuals to one of three groups to be given different doses of malaria by injection. These individuals will be further assigned to receive two different anti-malarial drugs (sub-curative treatment)</li>\n <li>\n For Phase B: Based on results from Phase A, give individuals malaria infection by injection at the most successful dose and provide sub-curative treatment that promotes the most transmission stages. At peak time points of transmission stage induction (based on results from Phase A), mosquito feeding assays will be undertaken to determine infectivity to mosquitoes.</li>\n</ol>\n<p>\n Multiple blood samples will be taken for those enrolled for malaria infections (both Phase A and B). For both phases, blood samples will be drawn as follows: a day before infection (40ml); at five days after infection (8ml); twice daily every day from seven days after infection until the day they will receive a sub-curative treatment (cumulative total of 185ml); and then once daily afterwards to twenty-one days after infection (cumulative total of 70ml); then every other day from day twenty-one until day forty-two (cumulative total of 71ml); once daily during curative treatment (cumulative total of 18ml);  and on day fifty-six after infection (40ml). In addition, for participants enrolled into Phase B, direct skin mosquito feeding and blood samples for mosquito membrane feeding assays will also be taken to assess mosquito infectivity (cumulative total of 28ml). The specific days for assessing mosquito infectivity will be dependent on the results from Phase A of the study. For the entire duration of the study (4-6months), a total of 465ml per participant of blood will be drawn for those enrolled in Phase A and a total of 493mls for those in Phase B. This total volume of blood is less than the volume taken during a blood donation. In addition to blood sampling, clinical assessments will be repeated a day before infection including collection of a urine sample and measurements of weights and heights. Observed sub-curative treatment for malaria will be administered on the day the parasites reach a set threshold and a curative dose on day forty-two after infection.</p>\n<address>\n <strong>What are the benefits and risks/costs of the study for those involved?</strong></address>\n<p>\n Controlled human malaria infection has been conducted in one hundred and eighty-nine (189) healthy adults in Kenya (Hodgson et al Front Microbiol. 2014 (Nairobi, N=28 volunteers, 2013) and KEMRI/SERU/CGMR-C/029/3190 (Kilifi, N=161 volunteers, 2016-2018)) and has been proven safe in these individuals. The risks relate to the possibility of developing an allergic reaction upon administration of the malaria infection. In addition, participants may develop signs and symptoms of malaria after infection which are unpleasant, may result in development of severe malaria due to the higher doses of sporozoites being given and may develop some side effects to the drugs used for treatment (sub-curative and curative doses). There are no direct benefits to individuals participating in this study other than information about their health. However, all participants will have their transport costs reimbursed and compensated for all out of pocket expenses for the entire duration of the study.</p>\n<address>\n <strong>How will the study benefit society?</strong></address>\n<p>\n This work is necessary for enhancing our understanding of how malaria transmission stages develop, the immune targets involved and ability to test interventions such as vaccines in populations that have past exposure to malaria. The successful application of such interventions will benefit society by reducing malaria transmission, a major cause of illness, death and impediment to national development. An adaptation of the controlled human malaria infection provides a way of studying transmission of malaria in a very detailed way that is not possible using natural infections, and we believe that this step is now necessary to inform vaccine design and efficacy.</p>\n<address>\n <strong>When does the study start and finish?</strong></address>\n<p>\n The study will start upon receipt of ethical clearance. Data collection, analysis and write up will take place over three years.</p>\n
      • short_titleUse of malaria infection by injection to study malaria transmission
      • protocol_noECCT/19/08/01
      • version_noVersion 3.0
      • date_of_protocol27-03-2019
      • study_drugPfSPZ Challenge CHMI-Transmod
      • disease_conditionMalaria
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@kemri-wellcome.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_addendum0
      • 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_applicantMelissa Kapulu
      • declaration_date105-08-2019
      • declaration_principal_investigatorMelissa Kapulu
      • declaration_date205-08-2019
      • placebo_presentNo
      • study_objectives<address>\n <strong>Primary objective</strong></address>\n<p>\n To adapt the Controlled Human Malaria Infection (CHMI) model using <em>P. falciparum</em> sporozoites to induce gametocytes and assess their infectivity to mosquitoes.</p>\n<p>\n <strong>Secondary objective(s)</strong></p>\n<address>\n 1. To determine the safety of varied increased doses of <em>P. falciparum</em> sporozoites in CHMI delivered by Direct Venous Inoculation (DVI) in semi-immune volunteers and optimise the dose of sporozoites that results in 100% infectivity in moderate to highly exposed adults;</address>\n<address>\n 2. To determine if the prevalence, peak density and peak time point of gametocytes is altered by drug-regimen and determine the area under the curve of density over time;</address>\n<address>\n 3. To determine the infectivity of drug-induced gametocytes in mosquito feeding assays;</address>\n<address>\n 4. To measure immunity to gametocyte antigens and determine associations between immunity and transmission-blocking activity in the CHMI model;</address>\n<address>\n 5. To explore the perceptions, attitudes, and experiences of research participants and other community and professional stakeholders involved in the CHMI study.</address>\n
      • principal_inclusion_criteria<ul>\n <li>\n Healthy adults aged 18 to 45 years.</li>\n <li>\n Able and willing (in the Investigator’s opinion) to comply with all study requirements.</li>\n <li>\n Informed consent.</li>\n <li>\n Use of effective method of contraception for duration of study (women only). We will ask the female volunteers to come with their family planning records to verify. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n Any of the following constitutes exclusion criterion:</p>\n<ul>\n <li>\n Body weight of less than 50kg or body mass index (BMI) less than 18 or greater than 25 kg/m² at screening.</li>\n <li>\n Use of systemic antibiotics with known antimalarial activity within 30 days of administration of PfSPZ Challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).</li>\n <li>\n Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.</li>\n <li>\n Current participation in another clinical trial or recent participation within 12 weeks of enrolment.</li>\n <li>\n Prior receipt of an investigational malaria vaccine.</li>\n <li>\n Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). This will also include Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) positivity.</li>\n <li>\n Use of immunoglobulins or blood products within 3 months prior to enrolment.</li>\n <li>\n Any serious medical condition reported or identified during screening that increases the risk of CHMI.</li>\n <li>\n Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.</li>\n <li>\n Women only; pregnancy, or an intention to become pregnant during the duration of the study.  </li>\n <li>\n Sickle cell trait or disease.</li>\n <li>\n History of drug or alcohol abuse.</li>\n <li>\n Known hypersensitivity to or contraindications for use of artemether-lumefantrine, chloroquine, piperaquine, primaquine, sulfadoxine-pyrimethamine, or history of severe (allergic) reactions to mosquito bites.</li>\n <li>\n Confirmed gametocyte positivity at screening and/or a day before challenge</li>\n <li>\n Confirmed parasite positive by PCR a day before challenge i.e. at C-1.</li>\n</ul>\n<p>\n <strong><em>Exclusion Criterion on Day of Challenge </em></strong></p>\n<ul>\n <li>\n Acute disease, defined as moderate or severe illness with or without fever (temperature >37.5^oC).</li>\n</ul>\n
      • primary_end_points<p>\n Not applicable. There are no primary endpoints.</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_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyHuman challenge study with deliberate infection of participants to induce transmission stages and understand immunogenicity.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Medical officer - 1<br />\n Clinical officer - 2<br />\n Nurses - 2<br />\n Fieldworkers - 5<br />\n Research and Assistant Research Officers - 2<br />\n Study Coordinator - 1<br />\n Pharmacisit - 1<br />\n Data Manager - 1<br />\n Data Clerk - 2<br />\n The inpatient facility is already staffed with 3 clincians, 1 paediatrician and 20 nurses.<br />\n All staff are trained in basic life support and resuscitation facilitaties are available.</p>\n
      • other_details_explanation<p>\n Not applicable.</p>\n
      • other_details_regulatory_notapproved<p>\n Submission is only to PPB.</p>\n
      • other_details_regulatory_approved<p>\n Not applicable.</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_duration3 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-Wellcome Trust Research Programme (KWTRP) Centre for Geographic Medical Research - Coast (CGMRC), Kilifi, Kenya.
      • single_site_physical_addressKEMRI-Wellcome Trust Research Programme, Off Bofa Road, Kilifi County Hospital, Kilifi, Kenya
      • single_site_contact_personMelissa Kapulu
      • single_site_telephone+254717501319
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site105
      • total_participants_worldwide105
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMelissa
      • investigator1_middle_name
      • investigator1_family_nameKapulu
      • investigator1_qualificationPhD
      • investigator1_professional_addressKEMRI-Wellcome Trust Research Programme, P. O. Box 230, Kilifi, Kenya 80108
      • investigator1_telephone+254709983463
      • investigator1_emailmkapulu@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants105
      • notification
      • approval_date15-11-2019
      • submitted1
      • deleted0
      • deleted_date2019-08-09 08:51:39
      • deactivated0
      • date_submitted27-02-2020
      • is_child0
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      • initial_date_submitted(null)
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      • final_date(null)
      • modified2024-07-29 09:25:54
      • created2019-07-18 14:56:05
      • total_sites(null)
      • ecitizen_invoice(null)
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      • 0(array)
        • id506
        • application_id816
        • given_nameMelissa
        • middle_name
        • family_nameKapulu
        • qualificationPhd
        • professional_addressKEMRI-Wellcome Trust Research Programme, P. O. Box 230, Kilifi, Kenya 80108
        • telephone+254709983463
        • emailmkapulu@kemri-wellcome.org
        • created2019-07-18 15:09:17
        • modified2020-02-27 12:45:15
      • 1(array)
        • id507
        • application_id816
        • given_namePhilip
        • middle_name
        • family_nameBejon
        • qualificationBSc MBBS PhD
        • professional_addressKEMRI-Wellcome Trust Research Programme, P. O. Box 230, Kilifi, Kenya 80108
        • telephone+254709983549
        • emailpbejon@kemri-wellcome.org
        • created2019-07-18 15:10:33
        • modified2020-02-27 12:45:15
    • SiteDetail(array)
      • 0(array)
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        • application_id816
        • county_id(null)
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        • created2019-07-18 15:09:17
        • modified2020-02-27 12:45:15
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id395
        • application_id816
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_person
        • addressUniversity Offices, Wellington Square, Oxford, OX1 2JD, UK
        • telephone_number+44 1865 270000
        • fax_number
        • cell_number+44 1865 270000
        • email_addressresearch.services@admin.ox.ac.uk
        • created2019-07-18 15:09:17
        • modified2020-02-27 12:45:15
  • 4(array)
    • Application(array)
      • id799
      • user_id32
      • trial_status_id7
      • abstract_of_study<div>\n  </div>\n<div>\n <div>\n <u>Background and rationale:</u> In malaria-endemic Africa, HIV and malaria conspire to increase the risks of adverse pregnancy outcomes. For HIV-infected pregnant women, WHO recommends daily cotrimoxazole (CTX) for chemoprevention for malaria and prophylaxis against opportunistic infection. However, there is cross-resistance with SP, and high levels of antifolate resistance threaten the antimalarial effect of CTX. Recent trials in HIV-infected pregnant women who received daily CTX plus IPTp with mefloquine, suggested that chemoprevention with an effective antimalarial markedly reduces the risk of malaria compared to daily CTX alone. However, mefloquine was not well tolerated. The long-acting combination of dihydroartemisinin–piperaquine (DP) is well tolerated and has shown great promise as IPTp in HIV-negative women in East-Africa. Chemoprevention with monthly DP has also been explored in HIV-infected women on daily CTX in Uganda. Unfortunately, the study was inconclusive as malaria transmission was too low. Furthermore, a clinically relevant drug-drug interaction between DP and efavirenz (EFV) was found to reduce DP drug levels. Following the recommendation from WHO, many countries in Africa are transitioning from EFV-based to dolutegravir (DTG) based combination antiretroviral therapy (cARTs). WHO now recommends DTG-based cARTS as the preferred first-line cART regimen in the 2nd and 3rd trimester of pregnancy. No such drug-drug interaction is expected between DTG and DP. We will therefore assess the safety and efficacy of malaria chemoprevention with monthly DP in HIV-infected women on daily CTX and DTG-based cARTs. We will therefore assess the safety and efficacy of malaria chemoprevention with monthly IPTp with DP in women on daily CTX and DTG-based cARTs and daily CTX.</div>\n <div>\n  </div>\n <div>\n <u>Overall aim: </u>To provide WHO with evidence on whether monthly IPTp-DP can improve current policies to control malaria in HIV-infected pregnant women on daily CTX in areas with high levels of parasite resistance and malaria in East and Southern Africa.</div>\n <div>\n  </div>\n <div>\n <u>Primary objective:</u> To determine if monthly IPTp-DP in HIV-infected pregnant women receiving daily CTX is safe and superior to daily CTX-alone for controlling malaria infection in areas with high antifolates resistance to SP and CTX in Malawi and Kenya.</div>\n <div>\n  </div>\n <div>\n <u>Hypotheses: </u>Monthly IPTp-DP in women receiving daily CTX is superior to daily CTX-alone in controlling malaria infection during pregnancy in HIV infected women on antiretroviral therapy.</div>\n <div>\n  </div>\n <div>\n <u>Overview Study Design: </u>This multi-centre trial will be conducted in antenatal clinics in 8 hospitals in Kenya and Malawi located in areas with high prevalence of HIV and malaria and with high anti-folate resistance of the malaria parasite. These are the same sites where the sister trial in HIV-uninfected women (all gravidae) is being conducted in Kenya and Malawi (IMPROVE trial: NCT03208179). Overall, 898 (449 per arm) HIV-infected pregnant women who are 16 to 28 weeks pregnant assessed by ultrasound dating, will be randomised to receive one of the two interventions. Permuted block randomisation stratified by site (i.e. hospital) and HIV-status (known-positive and newly-diagnosed) will be used. Allocation concealment will be ensured by using sequentially numbered, sealed, opaque envelopes. The study will include pharmacokinetic studies and cardiac monitoring in a sub group of women. Other components include molecular marker studies of antimalarial resistance. We will also look at the impact on biomarkers of placental function and trans-placental antibody transfer and multi-pathogen neonatal cell mediated immune responses.</div>\n <div>\n <div>\n  </div>\n <div>\n <u>Study Interventions: </u>Daily CTX for all trial participants receiving cARTs in addition to: a) monthly-DP (‘CTX-DP’), or b) monthly DP-placebo (‘CTX-alone’) (control).</div>\n <div>\n  </div>\n <div>\n <u>Follow-up procedures</u>: Monthly visits during pregnancy, and then at delivery. Mother and newborn follow-up at 7 days and 6-8 weeks post-partum.</div>\n <div>\n  </div>\n <div>\n <u>Primary outcome:</u> The cumulative incidence of malaria infection detected from 2 weeks after the first day of the first dose of the first course to delivery inclusive, defined as the presence of peripheral (maternal) or placental (maternal) Plasmodium infection detected by either molecular diagnostics (henceforth referred to as PCR), microscopy, RDT or placental histology (active infection).</div>\n <div>\n  </div>\n <div>\n <u>Sample size</u>: 898 (449 per arm), allowing for 20% loss to follow-up.</div>\n <div>\n  </div>\n <div>\n <u>Data Analysis</u>: Log-binomial regression will be used to analyse the primary outcome, controlled for site and gravidity.</div>\n <div>\n Primary partner institutions: KEMRI, Kenya; College of Medicine, University of Malawi, Malawi; Liverpool School of Tropical Medicine (LSTM); London School of Hygiene and Tropical Medicine (LSHTM); US Centers for Disease Control and Prevention (CDC); University of Bergen, Norway.</div>\n <div>\n  </div>\n </div>\n</div>\n<p>\n  </p>\n
      • study_title<div>\n <div>\n chemoprevention with monthly IPTp with dihydroartemisinin-piperaquine for malaria in HIV-infected pregnant participants on daily cotrimoxazole in Kenya and Malawi: a multi-centre placebo-controlled trial(IMPROVE-2).</div>\n</div>\n
      • laymans_summary<p>\n <strong><em> Context of the research: </em></strong>In malaria-endemic Africa, HIV and malaria conspire to increase the risks of pregnancy loss, preterm delivery, and growth retardation resulting in small babies. HIV-negative women in these areas receive intermittent preventive therapy in pregnancy (IPTp) with the antimalarial sulphadoxine-pyrimethamine (SP) to mitigate these effects. HIV-infected women receive daily prevention with cotrimoxazole (CTX), an antibiotic which also has antimalarial activity. However, the malaria parasite is increasingly resistant to SP and CTX. Recent trials with IPTp with mefloquine, when provided in addition to daily CTX, suggested that chemoprevention with an effective antimalarial markedly improves the protection against malaria in HIV-infected women compared to daily CTX alone. However, mefloquine was not well tolerated and other antimalarials are needed.</p>\n<div>\n The long-acting antimalarial dihydroartemisinin-piperaquine (DP) is well tolerated and has shown great promise in trials in HIV-negative women in Uganda and Kenya. Chemoprevention with monthly DP has also been explored in a small study (N=200) of HIV-infected women on daily CTX in Uganda. Unfortunately, the study was inconclusive because malaria transmission was low. It also showed a drug-drug interaction with the anti-retroviral efavirenz (EFV), which markedly reduced the protective drug levels of DP. Since this first trial, the preferred first-line combination antiretroviral therapy (cART) recommended by WHO for use in the 2nd and 3rd trimester changed to dolutegravir (DTG) based cARTs. No such drug-drug interaction is expected between DTG and DP. We will, therefore, assess the safety and efficacy of malaria chemoprevention with monthly DP in HIV-infected women on daily CTX and DTG-based cARTs.</div>\n<div>\n  </div>\n<div>\n <em><strong>Aim: </strong></em>To determine whether monthly IPTp-DP in HIV-infected pregnant women on cARTs and daily CTX improves current policies to control malaria in areas with high resistance to CTX and high prevalence of malaria in East & Southern Africa.</div>\n<div>\n  </div>\n<div>\n <em><strong>Methods:</strong></em> This is a 2-arm multi-centre trial involving 898 (449 per arm) women in 8 hospitals in Kenya and Malawi comparing daily CTX alone versus daily CTX plus monthly DP. The primary outcome is the incidence of malaria infection. This study is conducted alongside a sister trial among HIV-negative women (IMPROVE trial) also evaluating monthly DP.</div>\n<div>\n  </div>\n<div>\n <em><strong>Potential benefits and risks to participants: </strong></em>CTX and DP are currently thought to be safe for the mother and foetus during the second and third trimesters of pregnancy. The drugs have not yet been given concurrently in HIV-infected women on DTG-based cARTs, and the study will, therefore, include a nested cardiac monitoring component and a pharmacokinetic component to ensure women have adequate and safe drug levels. Examinations will be non-invasive, except for blood sampling which may cause minor discomfort. Participants experiencing illness between visits will be seen and treated free of charge as part of the study.</div>\n<div>\n  </div>\n<div>\n <strong><em>Potential applications: </em></strong>The study is designed to inform WHO policy in countries experiencing high levels of malaria parasite resistance and may potentially pave the way for new strategies to combat malaria in HIV-infected pregnant women hopefully resulting in healthier pregnancies and newborns.</div>\n
      • short_titleIMPROVE-2
      • protocol_noECCT/19/07/01
      • version_no1.0
      • date_of_protocol17-05-2019
      • study_drugDHA-Piperaquin vs CTX for IPTp
      • disease_conditionMalaria
      • 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_namedihydroartemisinin-piperaquine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstonysangke@gmail.com
      • applicant_covering_letter1
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      • applicant_investigators_brochure1
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      • applicant_signed_declaration1
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      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
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      • applicant_pan_african1
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Tony Sang
      • declaration_date101-07-2019
      • declaration_principal_investigatorDr Hellen Barsosio
      • declaration_date201-07-2019
      • placebo_presentYes
      • study_objectives<div>\n PRIMARY OBJECTIVE</div>\n<div>\n  </div>\n<div style=\"margin-left: 40px;\">\n To determine if monthly IPTp-DP in HIV-infected pregnant women receiving daily CTX is safe and superior to daily CTX-alone for controlling malaria infection in areas with high antifolates resistance to SP and CTX in Malawi and Kenya.</div>\n<div>\n  </div>\n<div>\n SECONDARY OBJECTIVES</div>\n<ol>\n <li>\n To determine if monthly IPTp-DP in HIV-infected pregnant women receiving daily CTX is safe and superior to daily CTX-alone for preventing adverse pregnancy outcomes due to malaria.</li>\n <li>\n To determine the effect of co-administration of DP and current first-line cARTs on the pharmacokinetic properties of piperaquine, first line cARTs and CTX</li>\n <li>\n To determine if the level of SP drug resistance, assessed by molecular markers, affects the potential impact of CTX.</li>\n <li>\n To determine the safety of monthly-DP in pregnant women receiving daily CTX and cARTs by conducting nested cardio monitoring studies.</li>\n <li>\n To determine if monthly IPTp-DP in HIV-infected pregnant women receiving daily CTX affects the risk of mother-to-child transmission of HIV infection.</li>\n <li>\n  To determine if monthly IPTp-DP in HIV-infected pregnant women receiving daily CTX reduces the risk of viral infections.</li>\n <li>\n To determine the impact of the interventions and prenatal exposure to HIV and/or malaria on adaptive and innate-like immune responses</li>\n</ol>\n
      • principal_inclusion_criteria<ul>\n <li>\n HIV-infected pregnant women between 16-28 weeks’ gestation</li>\n <li>\n Viable singleton pregnancy</li>\n <li>\n On or eligible for cARTs and CTX</li>\n <li>\n A resident of the study area</li>\n <li>\n Willing to adhere to scheduled and unscheduled study visit procedures</li>\n <li>\n Willing to deliver in a study clinic or hospital</li>\n <li>\n Provide written informed consent</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Multiple pregnancies (i.e. twin/triplets)</li>\n <li>\n HIV-negative or HIV status unknown</li>\n <li>\n Known heart ailment</li>\n <li>\n Severe malformations or non-viable pregnancy if observed by ultrasound</li>\n <li>\n Participants with advanced HIV-disease at WHO clinical stage 3 and 4</li>\n <li>\n Confirmed or suspected TB infection,</li>\n <li>\n Unable to give consent</li>\n <li>\n Known allergy or contraindication to any of the study drugs</li>\n</ul>\n
      • primary_end_points<p>\n Cumulative incidence of malaria infection detected from 2 weeks after the first day of the first dose of the first course to delivery inclusive</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study will be conducted in antenatal clinics and delivery units of Government or private (e.g. mission) hospitals and clinics with at least 30 new antenatal attendants per month in areas with year-round malaria transmission. The final choice of sites will depend on the available infrastructure and absence of planned malaria control interventions in the catchment area that might have a major impact on the malaria transmission intensity during the study period (e.g. planned mass campaigns to reduce malaria transmission such as indoor residual spraying [IRS]).</p>\n<p>\n will be conducted in approximately 3 to 5 Hospitals and satellite ANC clinics in the counties of the previous Western and Nyanza Provinces; including, but not limited to Busia, Siaya, Kisumu, Homa Bay and Migori counties in high malaria transmission areas in western Kenya. Suggested primary hospitals will include; Ahero sub-county hospital, Rabuor sub-county hospital and Akala sub-county hospital and the corresponding satellite clinics that refer patients to these hospitals.</p>\n<p>\n The key study staff will include the following:</p>\n<ul>\n <li>\n Chief Investigator – Prof Feiko ter Kuile, PhD</li>\n <li>\n Co-PI - Dr Hellen Barsosio, MD</li>\n <li>\n Co-PI - Dr Simon Kariuki, PhD</li>\n <li>\n Study Pediatrician Officer - Dr Martina Oneko, MD, MMed</li>\n <li>\n Pharmacist - Dr Tony Sang, BPharm</li>\n</ul>\n<p>\n Additionally, each of the sites will have the following personnel:</p>\n<ul>\n <li>\n Clinical Officers - 2</li>\n <li>\n Nurses - 2</li>\n <li>\n Lab Technicians/ Phlebotomist -1</li>\n <li>\n Field workers- 2</li>\n <li>\n Data Officers -1</li>\n <li>\n QA/QC officers -1</li>\n</ul>\n
      • other_details_explanation<p>\n Study will be conducted in the applicants country Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU approved this protocol on 03 May 2019</p>\n<p>\n LSTM Research Ethics Committee approved this protocol on </p>\n<div>\n  </div>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 months
      • 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_comparatorplacebo
      • 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 sites in Kenya
      • multi_country_listMalawi\nKenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site449
      • total_participants_worldwide898
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFeiko
      • investigator1_middle_nameter
      • investigator1_family_nameKuile
      • investigator1_qualificationMD, PhD,
      • investigator1_professional_addressLiverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK
      • investigator1_telephone+254 (0)708 739 228
      • investigator1_emailfeiko.terkuile@lstmed.ac.uk
      • organisations_transferred_No
      • number_participants449
      • notification
      • approval_date03-10-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted01-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results
      • quantity_importedDha-Piperaquine Tabs X 15,192tabs (Shipment1) plus 4914tabs (Shipment2) placebo Dha-Piperaquine Tabs 9/pk X 15,192tabs (Shipment1) plus 4914tabs (Shipment2)
      • quantity_dispensed29,526 tablets of DP/placebo DP in blinded packs
      • quantity_destroyedNone
      • quantity_exportedNone
      • balance_site10,794 tablets to be destroyed
      • final_date0000-00-00
      • modified2024-08-20 11:35:39
      • created2019-05-31 10:38:10
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      • ecitizen_invoice(null)
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        • given_nameHellen
        • middle_nameCherono
        • family_nameBarsosio
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        • professional_addressKEMRI Centre for Global Health Research (CGHR) and CDC Collaboration, P.O. Box 1578, Kisumu 40100
        • telephone+254 719 436 833
        • emailhellen.barsosio@lstmed.ac.uk
        • created2019-05-31 10:55:28
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        • professional_addressKEMRI Centre for Global Health Research (CGHR) and CDC Collaboration, P.O. Box 1578, Kisumu 40100
        • telephone+254 725 389 246
        • emailSKariuki@kemricdc.org
        • created2019-05-31 11:04:22
        • modified2020-05-01 07:38:18
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        • contact_personDr Hellen Barsosio
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        • created2019-05-31 10:55:28
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          • created2012-06-15 10:27:02
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        • contact_details+254 719 436833
        • contact_personDr Hellen Barsosio
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          • created2012-06-15 10:26:56
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        • sponsorLiverpool School of Tropical Medicine (LSTM)
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        • telephone_number+44 0151 7053794;
        • fax_number
        • cell_number+44 0151 7053794;
        • email_addresslstmgov@lstmed.ac.uk
        • created2019-05-31 10:55:28
        • modified2020-05-01 07:38:18
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    • 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