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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id5
      • user_id645
      • trial_status_id5
      • abstract_of_study<p>\n This is a 48-week, multicenter, multinational, open-label, randomized Phase 3b study to assess whether TDF/FTC/RPV shows noninferior response rates of HIV-1 RNA suppression <400 copies/mL, compared with the control group of TDF/FTC/EFV. Approximately 426 HIV-1 infected subjects, currently with HIV-1 RNA suppression <50 copies/mL on their first-line antiretroviral (ARV) regimen (NNRTI-based), will be randomized to 48 weeks treatment with a FDC regimen of either TDF/FTC/RPV or TDF/FTC/EFV (control group), in a ratio of 1:1. Randomization will be stratified based on the NNRTI the subject is taking at screening (either EFV or nevirapine [NVP]).</p>\n<p>\n The study will include a 6-week (maximum) screening phase, a 48-week (minimum duration) randomized open-label treatment phase, and a follow-up visit 30 to 35 days after the last dose of study drug. During the randomized open-label treatment phase, subjects will return for study visits at Week 4, 12, 24, 36, and 48 during the treatment period, and then every 24 weeks thereafter during the extended treatment period until the last subject has his or her Week 48 (or treatment discontinuation) visit.</p>\n<p>\n Throughout the open-label treatment phase, subjects will return for study visits as specified in the Time and Events Schedule to have procedures performed to assess efficacy (HIV-1 RNA levels, CD4+ cell count; testing performed at a central laboratory; see Efficacy Evaluations/Endpoints) and monitor safety (adverse events including HIV-related events, clinical laboratory analyses [central and local laboratory]; see Safety Evaluations). During the open-label treatment phase, if the HIV-1 RNA level is ≥50 copies/mL at any visit, subjects will have a blood sample collected for retesting at a central laboratory (and will continue to have blood samples collected) at up-to-8 week intervals until the plasma HIV-1 RNA level is <50 copies/mL, or virologic failure is confirmed by 2 consecutive plasma HIV-1 RNA levels ≥400 copies/mL.<br />\n <br />\n The end of the study is defined as the last subject, last follow-up visit in the study. The actual duration of treatment for each subject in the study will vary and will be determined by the length of time it takes to enroll all subjects. Therefore, with an expected enrollment period of 52 weeks, the treatment duration for each subject is expected to be between 48 and 108 weeks.<br />\n  </p>\n
      • study_title<p>\n <u><strong>S</strong></u>witching <u><strong>A</strong></u>t <u><strong>L</strong></u>ow HIV-1 RNA<u><strong> I</strong></u>nto <strong><u>F</u></strong>ixed Dose Combinations</p>\n<p>\n <strong>SALIF</strong></p>\n<p>\n Protocol Number: TMC278IFD3002 Amendment INT-1</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/04/08
      • version_noAMENDMENT INT-1
      • date_of_protocol30-07-2012
      • study_drugEVIPLERA® (Tenofovir Disoproxil/Emtricitabine/Rilpivirine) Fixed Dose Combination Tablet
      • disease_conditionHIV-1
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameemtricitabine/rilpivirine/tenofovir disoproxil fumarate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssherry@crafrica.com
      • applicant_covering_letter1
      • applicant_protocol1
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      • applicant_signed_declaration1
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      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
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      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
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      • 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_applicantSherry Armstrong-Wilkinson, Clininal Research Africa Ltd
      • declaration_date117-04-2013
      • declaration_principal_investigatorProfessor Edwin O Were
      • declaration_date217-04-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Each potential subject must satisfy all of the following criteria to be enrolled in the study. Each subject must:</p>\n<ol>\n <li>\n Be a man or woman, 18 years of age or older.</li>\n <li>\n Have documented HIV-1 infection.</li>\n <li>\n Have been receiving first line HAART for at least 1 year before the screening visit.<br />\n Note: HAART is defined as the combination of 2 N[t]RTIs with either EFV or NVP.  Previous changes in NRTI background regimen will be allowed. A switch from NVP to EFV is allowed, however subjects who have previously switched from EFV to NVP for toxicity reasons will not be eligible for the study.</li>\n <li>\n Have been taking the same ARV combination for at least 8 weeks before the screening visit and are expected to continue on this regimen throughout the screening period.</li>\n <li>\n Prefer (subject and physician’s preference) to change the current HAART regimen for reasons of simplification and/or N[t]RTI toxicity (examples of toxicities include but are not limited to: anemia, neutropenia, nausea, peripheral neuropathy, or paresthesia).</li>\n <li>\n Have plasma HIV-1 RNA <50 copies/mL at the screening visit (tested at central laboratory).</li>\n <li>\n Have CD4+ cell count >200/mm3 at screening visit (tested at central laboratory).</li>\n <li>\n Be able to comply with the protocol requirements. In particular, subjects should be willing to be followed up to Week 48 on subsequent treatment, even if they discontinue randomized treatment early.</li>\n <li>\n Have access to at least 1 meal a day.</li>\n <li>\n Have a normal ECG (or if abnormal, determined by the investigator to be not clinically significant;</li>\n <li>\n If heterosexually active, a female of childbearing potential and a non-vasectomized male subject who has a female partner of childbearing potential must agree to use effective contraceptives from screening onwards until 30 days (TDF/FTC/RPV) or 12 weeks (TDF/FTC/EFV) after completion of study treatment.</li>\n <li>\n If a woman of childbearing potential, she must have a negative serum β human chorionic gonadotropin (β hCG) pregnancy test at screening; and a negative serum or urine pregnancy test before the first dose of study drug.</li>\n <li>\n Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Any potential subject who meets any of the following criteria will be excluded from participating in the study. The subject will be excluded if he or she:</p>\n<ol>\n <li>\n Has a history of virologic failure, defined as 2 consecutive plasma HIV-1 RNA ≥400 copies/mL while on previous or current ART, if HIV-1 RNA data are locally available.</li>\n <li>\n Has a history of immunologic failure defined as 2 consecutive CD4+ cell counts during HAART treatment falling below the pre-HAART level, if CD4+ cell counts are locally available.</li>\n <li>\n Has a history of any primary N[t]RTI or NNRTI mutations (if testing performed locally, and results are available), as defined by the current International AIDS Society–USA (IAS-USA) 2011 guidelines.Error! Reference source not found. This list of mutations will be used throughout the study.  </li>\n <li>\n Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (hepatic insufficiency).</li>\n <li>\n Is diagnosed with acute clinical viral hepatitis at screening or before baseline.     <br />\n Note: Subjects with acute viral hepatitis A, B, or C are allowed to be re-screened when their condition is clinically stable and is not expected to require treatment during the study.    <br />\n Note: Subjects co-infected with chronic hepatitis B and/or C will be allowed to enter the study if AST and/or ALT levels are <5 times the upper limit of laboratory normal range (ULN) and if the subject’s condition is clinically stable and is not expected to require treatment during the study.</li>\n <li>\n Is infected with Mycobacterium tuberculosis which is likely to require rifampicin-based treatment during the study.  </li>\n <li>\n Has a grade 3 or 4 laboratory abnormality as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events criteria, with the following exceptions unless clinical assessment foresees an immediate health risk to the subject:</li>\n</ol>\n<ul style=\"margin-left: 40px;\">\n <li>\n Preexisting diabetes or with asymptomatic glucose grade 3 or 4 elevations.</li>\n <li>\n Asymptomatic triglyceride or cholesterol elevations of grade 3 or 4.</li>\n</ul>\n<ol start=\"8\">\n <li>\n Has presence of any currently active AIDS defining illness (Category C conditions according to the Center for Disease Control [CDC] Classification System for HIV Infection 1993;) with the following exceptions:<br />\n •    Stable cutaneous Kaposi’s Sarcoma (ie, no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study.<br />\n •    Wasting syndrome due to HIV infection.<br />\n Note: An AIDS defining illness that is not clinically stabilized for at least 30 days before the screening visit will be considered as currently active.</li>\n <li>\n Has creatinine clearance <50 mL/minute</li>\n <li>\n Is a woman who is pregnant or breastfeeding</li>\n <li>\n Is an active drug abuser, including alcohol or recreational drugs</li>\n <li>\n Has any active clinically significant disease (eg, TB, cardiac dysfunction, pancreatitis, acute viral infections) or life-threatening disease or findings during screening of medical history or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the study.</li>\n <li>\n Has any medical or psychiatric condition which, in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.</li>\n <li>\n Uses disallowed concomitant therapy.</li>\n <li>\n Is currently enrolled in an investigational drug study or has participated in an investigational drug study within the 4 weeks before screening.<br />\n  </li>\n</ol>\n
      • primary_end_points<p>\n The primary endpoint is the percentage of subjects in each treatment group (TDF/FTC/RPV and TDF/FTC/EFV) who have remained on randomized treatment and have plasma HIV-1 RNA levels <400 copies/mL at Week 48 using a modified version of the FDA snapshot method as described below.</p>\n<p>\n For this binary endpoint, a subject is classified as either a virologic responder or non-responder according to plasma HIV-1 RNA levels within the time window of the Week 48 visit and the time of randomized treatment discontinuation.   </p>\n<p>\n A subject is deemed a virologic responder only if 1 of the following 2 conditions applies based on the last available plasma HIV-1 RNA levels within the time window of the Week 48 visit (between Week 46 and Week 58):</p>\n<ol>\n <li>\n       This value <400 copies/mL; or</li>\n <li>\n       This value is <u>></u>400 copies/mL, but this represents a single, unconfirmed value; ie, it is not the second of 2 consecutive assessments <u>></u>400       copies/mL.        </li>\n</ol>\n<p>\n All subjects not classified as virologic responders are virologic non-responders. Therefore, the criteria for a subject to be classified as a virologic non-responder are the following:</p>\n<ul>\n <li>\n The occurrence of the second consecutive plasma HIV-1 RNA assessment <u>></u>400 copies/mL at Week 48. This could represent 2  assessments within the time window of the Week 48 visit (between Week 46 and Week 58), or a single assessment before Week 48, which is then confirmed at the Week 48 visit; or</li>\n <li>\n Discontinuation of randomized treatment due to any reason before Week 48. This includes discontinuations due to adverse events, lost to follow up, virologic failure before Week 48; or</li>\n <li>\n Missing plasma HIV-1 RNA data for any reason within the time window of the Week 48 visit (even if not discontinued before Week 48), irrespective of plasma HIV-1 RNA levels before and after the time window of the Week 48 visit.</li>\n</ul>\n<p>\n Note: In the primary efficacy analysis, the following subjects who need to switch to a non-study ART will not be classified as a treatment failure (unless they have had 2 consecutive HIV‑1 RNA levels ≥400 copies/mL): a female subject who becomes pregnant or a subject who requires treatment with rifampicin.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • 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_other1
      • trial_other_specifyPhase 3b non-inferiority trial
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Site KE00007 – Aga Khan Hospital</strong></p>\n<p>\n <strong>Number of Staff:</strong> 6</p>\n<p>\n  </p>\n<p>\n <strong>Names, Qualifications, Experience:</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:151px;\">\n <p>\n <strong>Names</strong></p>\n </td>\n <td style=\"width:123px;\">\n <p>\n <strong>Study Role</strong></p>\n </td>\n <td style=\"width:236px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:93px;\">\n <p>\n <strong>Years in Research</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Reena Shah</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBBS, MRCP, MScID</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  15</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Gerald Yonga</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Sub Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBchB, MMed, FRCP (Edin), MBA, FESC, FACC</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  25</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Kenneth Juma</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Coordinator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BSc.Uon</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  2</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Joyce Nduati</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Pharmacist</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BPharm</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  0</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Josephat Wambua</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  18</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Winrose Ogola</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Coordinator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n RN</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  0</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>Site Facilities: </strong></p>\n<p>\n The following equipment are available for this study; access controlled area for storage of IMP, a centrifuge, a -20C freezer and an interpretive ECG machine. These are and will be maintained and calibrated to ensure that all study required procedures can be conducted as per protocol.</p>\n<p>\n  </p>\n<p>\n Storage Area for Investigational Product</p>\n<p>\n Investigational product for this study will be under the direct control of the Principal Investigator and will be stored in access controlled cupboards with temperature monitoring in Room 523 of the Doctors Plaza.</p>\n<p>\n  </p>\n<p>\n Laboratory</p>\n<p>\n The Aga Khan central laboratories will be processing, packaging and shipping the samples to the central laboratories as required by the study protocol.  The laboratories offer state of the art equipment including, as required for this study centrifuges and -20C freezers.  Also available, if necessary. are<br />\n -80C freezers.  Staff are fully trained and carry the necessary IATA certification to ensure appropriate shipment of biological samples.</p>\n<p>\n  </p>\n<p>\n Consulting Rooms</p>\n<p>\n All potential participants will be consented and managed per study protocol with the Doctor’s Plaza at the Aga Khan hospital.  The consulting rooms ensure confidentiality for the subjects and storage of medical records in an access controlled environment.</p>\n<p>\n  </p>\n<p>\n <strong>Emergency Facilities:</strong></p>\n<p>\n The Aga Khan hospital within which the Doctor’s Plaza is situated is a fully equipped hospital with full emergency services, operating theatres and intensive care units ensuring that comprehensive emergency support can be provided within minutes.</p>\n<p>\n  </p>\n<p>\n <strong>Other relevant infrastructure:</strong></p>\n<p>\n None</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Site KE00008 – KEMRI – Walter Reed Project</strong></p>\n<p>\n <strong>Number of Staff:</strong> 20+</p>\n<p>\n  </p>\n<p>\n KEMRI/WRP KISUMU has about half-dozen US Army physicians and scientists who work closely with a core staff of over 200 Kenyans from diverse backgrounds to include 5 Kenyan senior MD or PhD principal investigators plus, junior physicians, clinical officers, clinical research coordinators, nurses, laboratory technicians, data entry clerks, psychosocial counsellors, archivists, QA/QC officers, a pharmacist and pharmacy technicians. These will offer secondary technical support for the SALIF study when needed. They include:</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:151px;\">\n <p>\n <strong>Names</strong></p>\n </td>\n <td style=\"width:123px;\">\n <p>\n <strong>Designation</strong></p>\n </td>\n <td style=\"width:236px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:93px;\">\n <p>\n <strong>Years in Research</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Colonel Ben Woods</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Site Director</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 1-5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Major Jessica Cowden</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Site Director</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MSPH</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n >10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Bernhards Ogutu</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, PhD</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n >10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Walter Otieno</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, PhD</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n >10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Nekoye Oysyula</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Lucas Otieno</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MPH</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n >10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Godfrey Allan Otieno</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MMED</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n >10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Ben Andagalu</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Ruth Wasuna</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Pharmacist</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BPharm, MBA</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Milton Omondi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n John Waitimbi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n DVM, PhD</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n >10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Peter Obare</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n DMLT</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Janet Oyieko</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MMED</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Christine Adhiambo</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n DMLT</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Fredrick Eyase</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n George Okoth</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Stacey Gondi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Victorine Owira</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BA</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Esther Oguk</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n RCO</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 1-5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Mercy Jacodull</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n RCO</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 1-5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Agnes Onyango</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n RN</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n >10</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Key Personnel who will be working on the SALIF study:</p>\n<p>\n Names, Qualifications and Experience</p>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:151px;\">\n <p>\n <strong>Names</strong></p>\n </td>\n <td style=\"width:123px;\">\n <p>\n <strong>Study Role</strong></p>\n </td>\n <td style=\"width:236px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:93px;\">\n <p>\n <strong>Years in Research</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Milton Omondi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MSc, CPI</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Nekoye Oysyula</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Associate Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Lucas Otieno</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MD, MPH</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n >10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Millicent Ouma</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study<br />\n Co-Ordinator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n Diploma in Nursing, BA</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 1-5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Ruth Wasuna</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Pharmacist</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BPharm, MBA</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Victorine Owira</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Director, Regulatory Affaris</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BA</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Jew Ochola</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Manager</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5-10</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Site Facilities, including emergency facilities and other relevant infrastructure:</strong></p>\n<p>\n  </p>\n<ol style=\"list-style-type:upper-alpha;\">\n <li>\n Physical infrastructure</li>\n</ol>\n<p>\n KEMRI/WRP-Kisumu conducts regulated human use trials and basic science research directed at the development of vaccines, drugs, and rapid diagnostic tests for tropical diseases of Africa and the world.  The Kombewa Clinical Research Center is approximately 10,000 square foot complex, dedicated to conducting large trials. It contains administrative rooms, clinical examination rooms, clinician work areas/offices, monitoring space, clinical waiting area, counseling rooms, post-treatment observation area, data archive, emergency room with a crash-cart, IT server room and data room. The site is designed to ensure efficient client flow and staffing.</p>\n<p>\n  </p>\n<p>\n The facility derives its electric power supply from the Kenya government main supply lines. Additionally, there’s a diesel generator power back-up in case of blackouts/brownouts.</p>\n<p>\n There’s documented scheduled generator maintenance.</p>\n<ol style=\"list-style-type:upper-alpha;\">\n <li value=\"2\">\n Pharmacy</li>\n</ol>\n<p>\n The Kombewa CRC pharmacy is approximately 10square meters in surface area and is air-conditioned, with 24 hour temperature monitoring. There are procedures and systems to notify the pharmacy staff, whether they are present or are away, of temperature deviations in the storage areas. Additionally, an audible alarm goes off to notify guards at night in case of any temperature deviation. The pharmacy has a controlled access with only authorized staff allowed to enter the pharmacy. Visitors must sign entry logs and blinded study staffs are not allowed access to the pharmacy.</p>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<p>\n The pharmacy has a system for organizing study documents to ensure accurate recording, verification and retrieval of information. These are guided by SOPs that are reviewed annually and a written quality management plan. All study accountability records are available for inspection on demand. Additionally, the pharmacy maintains written records of all study products that have been received, dispensed, returned or destroyed.</p>\n<p>\n  </p>\n<p>\n Equipment available at the pharmacy includes:</p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Refrigerators with 24hour temperature monitoring and alarm system that goes off incase of temperature deviation.</li>\n <li>\n Back-up power supply with UPS batteries.</li>\n <li>\n Biosafety cabinet for preparing study products.</li>\n <li>\n Two-door lockable isolator cabinet for storing study products that don’t need refrigeration.</li>\n <li>\n Dedicated printer and scanner.</li>\n <li>\n Potable water with water dispenser.</li>\n <li>\n Computers with internet access.</li>\n</ol>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<p>\n All pharmacy staffs are GCP-trained and are highly experienced in conducting vaccine and therapeutic clinical trials, including phase 1, phase 2 and phase 3 trials. They are knowledgeable on all Kenyan laws and regulations governing the import and export of investigational products. There’s a pharmacist on call after hours to handle any unexpected issues arising from the pharmacy.</p>\n<p>\n  </p>\n<ol style=\"list-style-type:upper-alpha;\">\n <li value=\"3\">\n <u>Clinical laboratory</u></li>\n</ol>\n<p>\n Kombewa CRC has the following capacity:</p>\n<ol>\n <li>\n Clinical chemistry. Two fully automated analyzers with continuous and random-access features for routine chemistries, specific proteins, electrolytes, hormones, therapeutic drugs, and drugs of abuse with capacity of 320 tests per hour. Point of care hand held blood analyzers for quantification of blood gases, electrolytes glucose and coagulation times. A number of rapidly field deployable glucose and Hb meters.</li>\n <li>\n Hematology. Two automated hematology analyzers with capabilities of 5 part and 3 –part differentials. Semi automated ELISA system with a capacity of 96 samples. A variety of rapid diagnostic tests including tests for HIV, HBV, HCV and malaria parasites.</li>\n <li>\n Microscopy; Microscopic slide reading with over 10 certified malaria microscopists.</li>\n <li>\n Microbiology; Two automated blood culture machines (Bactec) with a capacity of 100 specimens for identification of blood pathogens. Identification of pathogens from clinical specimens to include blood pathogens, enteric pathogens, CSF, urine and swabs of purulent drainage using culture techniques and serological tests. Rapid detection of CSF pathogens using antigen detection kits. Antibiotic resistance testing of isolated pathogens following CLSI and the Kenya-MOH guidelines. Capabilities for ESBL and MRSA testing; ova and parasite screen.</li>\n <li>\n Other equipment/facilities available in the laboratory include -80°C freezers, bio-safety cabinets, water baths, centrifuges, dry ice, liquid nitrogen, PBMC processing, and TB diagnosis (smear and quantiferon)</li>\n</ol>\n<p>\n The laboratory can track stored specimen using freezer works and bar-coded aliquot labels. We have previously shipped out samples internationally.</p>\n<ol style=\"list-style-type:upper-alpha;\">\n <li value=\"4\">\n <u>Communication/IT </u></li>\n</ol>\n<p>\n Local and international cell phone access is available, as is Blackberry service. The unit runs on a DELL platform for its servers using Microsoft Windows 2003 in conjunction with Microsoft Exchange 2003 for E-mail, while client computers both laptops and desktops run on Windows XP and Vista.  WRP has its own Wide Area Network spanning three sites totaling 100 nodes/users interconnected by broadband wireless in Kisumu town. Internet services are available through VSAT. Data management is done onsite using SQL Server and Microsoft Access Database Management Systems.</p>\n<ol style=\"list-style-type:upper-alpha;\">\n <li value=\"5\">\n <u>Clinical evaluations capabilities</u></li>\n</ol>\n<p>\n Facilities/services available for clinical evaluations include:</p>\n<ul>\n <li>\n Clear View ®Ultrasound</li>\n <li>\n Digital X-Ray machine</li>\n <li>\n Skin test (PPD)</li>\n <li>\n Lumbar Puncture</li>\n <li>\n Crash Cart: This is well maintained with an up-to-date maintenance log, equipment calibration log and a written emergency plan.</li>\n</ul>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<ol style=\"list-style-type:upper-alpha;\">\n <li value=\"6\">\n <u>Health and Demographic Surveillance System (HDSS)</u></li>\n</ol>\n<p>\n WRP Kisumu has a fledgling Health and Demographic Surveillance System (HDSS) in Kisumu West District in which it mapped all buildings and structures; followed by a demographic/health surveillance survey. The HDSS can provide a detailed demographic profile of Kisumu West residents, including age, gender, level of education, socio-economic status, religion, access to social amenities/services, female parity among others.</p>\n<ol style=\"list-style-type:upper-alpha;\">\n <li value=\"7\">\n <u>Community Advisory Board (CAB)</u></li>\n</ol>\n<p>\n KEMRI/WRP Kisumu has a functional Community Advisory Board (CAB) which acts as the liaison between the community and the research team. It ensures that research strategies respect the values and culture of Kisumu West community while also ensuring that the community has a better understanding of health research. The CAB members bring unique perspectives from the communities they represent. These perspectives and diversity ensure a wholesome decision making process in the conduct of KEMRI/WRP trials and/or research activities. CAB membership is voluntary and it operations are guided by an SOP. It operates as an advisory body with decisions made through consultation and consensus. It has at least 12 members and not more than 24 members at any given time. Its membership is identified from among the key stakeholders from multiple sectors within the target community of Kisumu West District. The CAB meets every 3 months and/or at a frequency determined by the members. Its membership is diverse to reflect gender equity and the type of participants normally involved in the clinical trials or their representatives. These include:</p>\n<ul>\n <li>\n Youth group representative</li>\n <li>\n Study volunteers/former study volunteers</li>\n <li>\n Clergy representative</li>\n <li>\n Health facilities representative</li>\n <li>\n Teachers group representative</li>\n <li>\n Women group representative</li>\n <li>\n Community health workers representative</li>\n <li>\n Health NGO/Civil society representative (operating in Kisumu West District)</li>\n <li>\n Persons with disability representative</li>\n <li>\n Ex officio members-\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n KEMRI/WRP (Chief of Community Relations, Investigators, CRCs etc),</li>\n <li>\n MOH-District Public Health Nurse, District Medical Officer of Health etc.</li>\n <li>\n Provincial Administration-District Officer, chief, village elder</li>\n </ol>\n </li>\n</ul>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Site KE00009 – Partners in Prevention, Eldoret</strong></p>\n<p>\n <strong>Number of Staff:</strong> 14 key study staff.  Additional staff provide financial and administrative support.</p>\n<p>\n  </p>\n<p>\n <strong>Names, Qualifications, Experience:</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:151px;\">\n <p>\n <strong>Names</strong></p>\n </td>\n <td style=\"width:123px;\">\n <p>\n <strong>Designation</strong></p>\n </td>\n <td style=\"width:236px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:93px;\">\n <p>\n <strong>Years in Research</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Edwin Were</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB, MMed, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  19</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Paul Ayuo</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Sub Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB, MMed, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  15</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Abraham Siika</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Sub Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB, MMed, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Dismas Oketch</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Coordinator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Simon Wachira</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Pharmacist</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BPharm</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Wilfred Emonyi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Manager</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n PhD</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  25</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Priscilla Chepkorir Cheruiyot</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Clinical Trials Manager</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BSN, MPH</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Allan K. Sudoi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Regulatory Affairs Coordinator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BSc EVH, Dip IT</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Francis Musamali Mudogo</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Accountant/ Administrator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n KATC</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  9</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Mercy Jelagat Karoney</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Medical Officer</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  1</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Betty Jerop Meli</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Clinical Officer</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n Dip Clinical Medicine</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  8</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Martha Bisieri Mokaya</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Data Manager</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BSc, MSc</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Cecilia Chebet Mengich</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Recruitment Officer</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n Dip Social Work/Dip Disaster Management</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Chris Sande Mboya</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Nurse Counsellor</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n KRCHN</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  1</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>Site Facilities: </strong></p>\n<p>\n The following equipment, is available, maintained and calibrated to ensure that all study required procedures can be conducted as per protocol.</p>\n<p>\n  </p>\n<p>\n The Eldoret Site currently runs ACTG clinical trials.</p>\n<p>\n  </p>\n<p>\n Pharmacy</p>\n<p>\n There is a study pharmacy ensuring that all study medications can be stored, dispensed and returned in accordance with study requirements; for this study, product will be stored in an access-controlled environment and maintained at a temperature between 15-30^oC .</p>\n<p>\n  </p>\n<p>\n Laboratory</p>\n<p>\n The site incorporates the AMPATH Reference Laboratory providing access to all required facilities for this study, specifically: three -80C and four  - 20C freezers and multiple centrifuges.  The laboratory is staffed by appropriately trained personnel ensuring that IATA regulations for the shipping of biological samples are adhered to.<br />\n The laboratory is located on the first floor of the AMPATH Center building within which the study clinic is situated.</p>\n<p>\n  </p>\n<p>\n Consulting Rooms</p>\n<p>\n The site is set-up to ensure private consulting rooms ensuring confidentiality when consenting and during subject visits.  Separate counseling rooms are available, if required.  A study specific 12 lead interpretive ECG will be purchased and be in place prior to site initiation.</p>\n<p>\n  </p>\n<p>\n Emergency Facilities:</p>\n<p>\n A comprehensive emergency service (Moi University Hospital) is accessible within minutes, providing full medical, surgical and intensive care facilities.</p>\n<p>\n  </p>\n<p>\n <strong>Other relevant infrastructure:</strong></p>\n<p>\n None</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Site KE00011 – KAVI Kenyatta Hospital</strong></p>\n<p>\n <strong>Number of Staff:</strong> >20</p>\n<p>\n  </p>\n<p>\n <strong>Names, Qualifications, Experience:</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:151px;\">\n <p>\n <strong>Names</strong></p>\n </td>\n <td style=\"width:123px;\">\n <p>\n <strong>Designation</strong></p>\n </td>\n <td style=\"width:236px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:93px;\">\n <p>\n <strong>Years in Research</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Prof. Omu Anzala</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Program Director</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB, Diploma Epidemiology, PhD Medical Microbiology and Infectious Diseases, post doc fellow Molecular Immunology Group Institute of Molecular Medicine Oxford University</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Prof. Walter Jaoko</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Deputy Program Director</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB, MSc Tropical Medicine, Diploma Research Methodology, PhD Medical Microbiology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Prof. Kirana Bhatt</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Consultant Physician</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB, MMed internal medicine, MSc Clinical Tropical Medicine, PhD</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Gina Ouattara</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 3.5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Gloria Omosa-Manyonyi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Sub-Investigator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n MBChB, MSc Infectious Diseases</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Jacquelyn Nyange</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Coordinator - Regulatory</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n KRN, BA Psychology, MSc Clinical Psychology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Elizabeth Mutisya</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Coordinator – Clinic level</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n KRCHN, BA Psychology and Sociology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 2</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Hilda Ogutu</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Senior Study Nurse</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n KRM, KRCHN, BScN</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 11</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Rose Ndambuki</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Study Nurse</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n KRCHN, HND Counseling, BA Psychology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Catherine Kamau</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Pharmacist</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n KRCHN and Certificate in Counselling</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Roselyne Malogo</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Community Coordinator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n KRCHN, Certificate in Conflict Resolution, BA Community Development</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 8</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Rose Mahira</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Community Coordinator</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n ECN, Diploma in counseling, BA Psychology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 8</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Bashir Farah</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Manager</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n HND Virology, MSc Virology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 16</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Jackton Indagasi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Quality Assurance Manager</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n PGD Infectious Diseases, MSc Infectious diseases</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Robert Langat</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory and Site Safety Officer</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BSc Medical Laboratory Technology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Simon Ogolla</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Technician</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n HND Microbiology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Stella Njoroge</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Technician</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n HND Laboratory Technology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 8</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Irene Mwangi</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Technician</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n Diploma Laboratory Technology, BSc Laboratory Technology</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 2</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Ruth Chirchir</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Laboratory Technician</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BSc Biological Sciences</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Moses Muriuki</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Data/IT Manager</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BSc Software Engineering</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Laura Lusike</p>\n </td>\n <td style=\"width:123px;\">\n <p>\n Data assistant</p>\n </td>\n <td style=\"width:236px;\">\n <p>\n BA home economics</p>\n </td>\n <td style=\"width:93px;\">\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:151px;\">\n <p>\n Additional personnel</p>\n </td>\n <td colspan=\"3\" style=\"width:452px;\">\n <p>\n Administrative, Finance and support staff</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Site facilities:</p>\n<ul>\n <li>\n Reception</li>\n <li>\n Waiting room for volunteers</li>\n <li>\n Counseling rooms  - 2</li>\n <li>\n Patient examination rooms – 3</li>\n <li>\n Full pharmacy facilities (room temperature, refrigerated and frozen storage facilities, all temperature controlled) with limited access</li>\n <li>\n Study records filing room – limited access using swipe card</li>\n <li>\n Laboratories – swipe access\n <ul style=\"list-style-type:circle;\">\n <li>\n safety laboratory </li>\n <li>\n immunology laboratory</li>\n </ul>\n </li>\n <li>\n Data room – limited access with swipe card\n <ul style=\"list-style-type:circle;\">\n <li>\n Pre – archive room – swipe card access</li>\n <li>\n Data entry computers – 4</li>\n <li>\n Online and offline data entry capabilities</li>\n <li>\n Data faxing</li>\n <li>\n Internet – upload and download bandwidth of 1MB/second and backup modems from mobile service providers</li>\n <li>\n Backup UPS of 4 – 6 hours and backup generator</li>\n </ul>\n </li>\n <li>\n Kitchenette – for staff and volunteer refreshments</li>\n <li>\n Meeting room</li>\n</ul>\n<p>\n Emergency facilities:</p>\n<ul>\n <li>\n One of the patient examination rooms is equipped as an emergency room with oxygen tank and mask, suction pump machine with suction tubes, defibrillator, nebulizer, laryngoscope, endotracheal tubes, airway, adult ambu bag and mask, giving sets.</li>\n <li>\n Emergency stretcher</li>\n <li>\n Emergency drugs in stock –\n <ul style=\"list-style-type:circle;\">\n <li>\n Parenteral - hydrocortisone, adrenaline, paracetamol, hyosine, atropine, lidocaine, lignocaine, aminophylline, sodium bicarbonate, metoclopramide, diazepam, chlorpheniramine, calcium gluconate,</li>\n <li>\n Salbutamol nebulizer solution</li>\n <li>\n IV fluids – 5% dextrose, 50% dextrose, normal saline</li>\n <li>\n Post exposure prophylaxis – combivir and kaletra</li>\n </ul>\n </li>\n <li>\n Patients can then be transferred to Kenyatta National Hospital emergency department or admitted to the wards for further care.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Other relevant infrastructure:</strong></p>\n<p>\n None relevant to the TMC278IFD3002 study</p>\n<p>\n  </p>\n<p>\n <strong>Site KE00013 – KAVI Kangemi</strong></p>\n<p>\n <strong>Number of Staff:</strong> 11 plus support staff</p>\n<p>\n  </p>\n<p>\n <strong>Names, Qualifications, Experience:</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:140px;\">\n <p>\n <strong>Names</strong></p>\n </td>\n <td style=\"width:126px;\">\n <p>\n <strong>Designation</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:125px;\">\n <p>\n <strong>Years of Research Experience</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n John Gachie</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n BSc Applied Biology (2011)</p>\n <p>\n MSc Molecular Biology & Informatics (On-going)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 8</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Catherine Kamau</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Pharmacist</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Diploma Nursing (2007)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Laura Lunani</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Data Entry</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n BSc Family and Consumer sciences (2003)</p>\n <p>\n Multivariate Statistics course using STATA 11 (2011)</p>\n <p>\n Qualitative Research Methodologies (2012)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Amos Maina</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Data Entry/IT</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Diploma in programming and data management (2005)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Raymond Murungi</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Nurse Counsellor</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Kenya Registered Community Health Nurse (2006)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Gaudensia Mutua</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n MBChB (1995)</p>\n <p>\n MPH (2005)</p>\n <p>\n PgDip (Epidemiology) (2011)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Jane Nganga</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Community Mobilizer/Nurse Counsellor</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n BA Counselling Psychology (2011)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Delvin Nyasani</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Study Coordinator/ Nurse Counsellor</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Diploma Community Health Nursing (2000)</p>\n <p>\n BSc Nursing (on-going)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 6</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Geoffrey Ombati</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Clinical Officer</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Diploma Clinical medicine & Surgery (2008)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 2.5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Linda Otsianda</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Community Mobilizer/Back-up Pharmacist</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Kenya Registered Community health nurse (2005)</p>\n <p>\n Higher Diploma Epidemiology (2011)</p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Rose Sajabi</p>\n </td>\n <td style=\"width:126px;\">\n <p>\n Nurse Counsellor/ Assistant Study Coordinator</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n BA Psychology (2011)</p>\n <p>\n  </p>\n </td>\n <td style=\"width:125px;\">\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:140px;\">\n <p>\n Additional personnel</p>\n </td>\n <td colspan=\"3\" style=\"width:464px;\">\n <p>\n Administrative, Finance and support staff</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>Site Facilities</strong></p>\n<p>\n  </p>\n<p>\n The KGM clinic is located on the grounds of the Kangemi community health centre. The clinic is largely made up of refurbished shipping containers and comprises eight clinic rooms, a mini-lab, an investigational product pharmacy, a general pharmacy, a data management room, a community meeting room, and administrative offices. Routine medical care for trial participants is provided on-site at the clinic, including general medical care, medication dispensing, HIV VCT, family planning counseling and provision of HIV post-exposure prophylaxis.   The clinic includes resuscitation equipment including a cardiac defribrillator, oxygen and intravenous access in the event of anaphylaxis. It is equipped for protocol specific requirements such as pelvic examinations, genital specimen collections with a specific room for mucosal specimen collections. It has teleconference facilities and ability to conduct audio computer-assisted interviews (ACASI).</p>\n<p>\n  </p>\n<p>\n <u>Pharmacy:</u> The investigational product pharmacy measures 9.56m² and is located on the 1^st floor as part of a larger modified shipping container. The pharmacy has a Sanyo MDF -80°C freezer, a Sanyo refrigerator and a class II biosafety cabinet. The room has an air conditioner and an inverter/battery system that acts as backup to the 27KVa generator on site.  Transmitters connected to the freezer and fridge send data to the pharmacy computer, which is programmed to call relevant staff in the event of temperature excursions or power failure.  Room temperature can also be controlled in a similar manner. Access to the pharmacy is restricted and is limited to the three pharmacy staff. The pharmacy at the Kangemi clinic acts as a back-up to the KNH clinic (and vice versa) in case of generator and/or battery failure.</p>\n<p>\n  </p>\n<p>\n <u>Laboratory:</u> The mini-lab has capacity to conduct pregnancy testing, urinalysis, RPR and blood glucose. Samples are transported twice a day to the main lab at the KNH clinic by car, a trip of 10Km, approximately 40-60 minutes depending on prevailing traffic.</p>\n<p>\n  </p>\n<p>\n <u>Data:</u> Data management is mainly through online data capture system (in collaboration with EMMES corporation USA) and datafax (in collaboration with the Perinatal HIV research unit South Africa). In addition to the electronic swipe cards that limit access to the data office, access to the database is password controlled and staff have limited access levels to the database. Study documents that contain volunteer identifiers are stored separately in fireproof cabinets.</p>\n<p>\n  </p>\n<p>\n <strong>Emergency Facilities:</strong></p>\n<p>\n The clinic includes resuscitation equipment including a cardiac defribrillator, oxygen and intravenous access in the event of anaphylaxis.  If required, participants will be transferred to Kenyatta National Hospital for medical/surgical and or intensive care facilities.</p>\n<p>\n  </p>\n<p>\n <strong>Other relevant infrastructure:</strong></p>\n<p>\n None relevant to the TMC278IFD3002 study</p>\n
      • other_details_explanation<p>\n Sub-Saharan Africa is more heavily affected by HIV and AIDS than any other region of the world. An estimated 22.9 million people are living with HIV in the region - around two thirds of the global total.<br />\n <br />\n This study is being conducted in countries where it is expected to have efavirenz (EFV) and rilpivirine (RPV)-based regimens available at the time the study is expected to be finished.  In these resource-limited settings the alternatives for Fixed Dose Combination therapies are limited.  </p>\n<p>\n <br />\n In resource limited settings, simple programmatic rollout of ARTs in FDCs is needed. The World Health Organization (WHO) recommends TDF, 3TC or FTC, and EFV as a FDC, taking into account existing data, available compounds, and regimens currently recommended as preferred first-line options in the 2010 ART guidelines. Further, the 2020 WHO goal is to have effective, affordable, one pill, once-daily potent ARV regimens with minimal toxicities or drug interactions and high barriers to resistance available in low and middle-income countries.</p>\n<p>\n <br />\n If the efficacy of TDF/FTC/RPV is shown to be non-inferior to TDF/FTC/EFV in this setting, the FDC of TDF/FTC/RPV could provide an effective, well-tolerated and affordable alternative therapy.<br />\n  </p>\n
      • other_details_regulatory_notapproved<p>\n 1. Health Research and Development Council, Botswana 9th October 2012 - application withdrawn on 01 February 2013 by Sponsor as Botswana will not participate in this study.<br />\n 2. Medicines Control Council, South Africa - Submitted16th November 2012<br />\n 3. National Drug Authority, Uganda - Submitted 5th April 2013<br />\n  </p>\n
      • other_details_regulatory_approved<p>\n None, to date</p>\n
      • other_details_regulatory_rejected<p>\n This trial has received no rejections from Ethics Committees ot Health Authorities to date.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_durationUp to two years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorTenofovir Disoproxil Fuma
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states8
      • number_of_sitesFive
      • multi_country_listKenya, Uganda, South Africa, Cameroon, Ghana, Senegal, Thailand and Vietnam
      • data_monitoring_committeeYes
      • total_enrolment_per_site<15, non-competitive enrolment
      • total_participants_worldwide426
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameEdwin
      • investigator1_middle_nameOnyango
      • investigator1_family_nameWERE
      • investigator1_qualificationMBChB; MMed (O/G); MPH
      • investigator1_professional_addressDepartment of Reproductive Health, Moi University School of Medicine, P.O. Box 4606 - 30100 Eldoret. Physical Address: MTRH Outpatient Building, Rm 197, Nandi Road, Eldoret, Kenya
      • investigator1_telephone(null)
      • investigator1_email(null)
      • organisations_transferred_Yes
      • number_participants<75
      • notification
      • approval_date30-07-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-04-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2022-11-16 04:16:17
      • created2013-01-23 13:04:25
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id2
        • application_id5
        • given_nameEdwin
        • middle_nameOnyango
        • family_nameWERE
        • qualificationMBChB; MMed (O/G); MPH
        • professional_addressDepartment of Reproductive Health, Moi University School of Medicine, P.O. Box 4606 - 30100 Eldoret. Physical Address: MTRH Outpatient Building, Rm 197, Nandi Road, Eldoret, Kenya
        • telephone(null)
        • email(null)
        • created2013-01-23 13:22:58
        • modified2013-04-17 18:02:40
      • 1(array)
        • id3
        • application_id5
        • given_nameMilton
        • middle_nameTony
        • family_nameOMONDI
        • qualificationMBChB
        • professional_addressKEMRI/Walter Reed Project-Kombewa; Opposite Kombewa District Hospital, Off Kisumu Bondo Highway, Kisumu, Kenya
        • telephone(null)
        • email(null)
        • created2013-01-23 13:52:36
        • modified2013-04-17 18:02:40
      • 2(array)
        • id4
        • application_id5
        • given_nameGina
        • middle_name
        • family_nameOUATTARA
        • qualificationMBChB
        • professional_addressKenya AIDS Vaccine Initiative, University of Nairobi, Department of Medical Microbiology 2nd Floor, Nairobi, Kenya
        • telephone(null)
        • email(null)
        • created2013-01-23 13:52:36
        • modified2013-04-17 18:02:40
      • 3(array)
        • id5
        • application_id5
        • given_nameGaudensia
        • middle_nameNzembi
        • family_nameMUTUA
        • qualificationMBChB; MPH;
        • professional_addressKangemi Health Centre, Kenya AIDS Vaccine Initiative, University of Nairobi, Department of Medical Microbiology 2nd Floor, Nairobi, Kenya
        • telephone(null)
        • email(null)
        • created2013-01-23 13:52:36
        • modified2013-04-17 18:02:40
      • 4(array)
        • id6
        • application_id5
        • given_nameReena
        • middle_name
        • family_nameSHAH
        • qualificationMBBS; MRCP (London); Diploma in Infectious Diseases (LSTMH): Masters in Infectious Diseases (London)
        • professional_addressAga Khan University Hospital, Room 523, 5th floor Drs Plaza, Aga Khan University Hospital, PO Box 30270-00100, Nairobi, Kenya
        • telephone(null)
        • email(null)
        • created2013-01-23 13:52:36
        • modified2013-04-17 18:02:40
    • SiteDetail(array)
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        • application_id5
        • county_id47
        • site_nameAga Khan University Hospital
        • physical_addressRoom 523, 5th Floor Doctors Plaza, Aga Khan University Hospital, 3rd Parklands Avenue, Nairobi, Kenya
        • contact_detailsTelephone: 020 366 2788; eMail: Reena.Shah@aku.edu
        • contact_personDr Reena Shah (Principal Investigator)
        • site_capacity(null)
        • misc(null)
        • created2013-01-23 13:22:58
        • modified2013-04-17 18:02:40
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id11
        • application_id5
        • county_id42
        • site_nameKEMRI/Walter-Reed Project Kombewa
        • physical_addressOpposite Kombewa District Hospital, Off Kisumu Bondo Highway, Kisumu, Kenya
        • contact_detailsTelephone: 073 333 3353; eMail: Milton.Omondi@usamru-k.org
        • contact_personDr Milton Omondi (Principal Investigator)
        • site_capacity(null)
        • misc(null)
        • created2013-01-24 10:51:12
        • modified2013-04-17 18:02:40
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id12
        • application_id5
        • county_id27
        • site_namePartners in Prevention
        • physical_addressMU-CRS, AMPATH Centre at Moi Teaching and Referral Hospital, Eldoret, Kenya
        • contact_detailsTelephone: 053 206 0850; eMail: eowere@gmail.com
        • contact_personProfessor Edwin Were (Principal Investigator)
        • site_capacity(null)
        • misc(null)
        • created2013-01-24 10:51:12
        • modified2013-04-17 18:02:40
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 3(array)
        • id13
        • application_id5
        • county_id47
        • site_nameKenya AIDS Vaccine Initiative - KNH
        • physical_addressUniversity of Nairobi, Department of Medical Microbiology 2nd Floor, Nairobi, Kenya
        • contact_detailsTelephone: 072 220 7417; eMail: GOuattara@kaviuon.org
        • contact_personDr Gina Ouattara (Principal Investigator)
        • site_capacity(null)
        • misc(null)
        • created2013-01-24 10:51:12
        • modified2013-04-17 18:02:40
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id14
        • application_id5
        • county_id47
        • site_nameKenya AIDS Vaccine Initiative - Kangemi
        • physical_addressKangemi Health Centre, Kangemi, Nairobi, Kenya
        • contact_detailsTelephone: 072 425 6131; eMail: GMutua@kaviuon.org
        • contact_personDr Gaudensia Mutua (Principal Investigator)
        • site_capacity(null)
        • misc(null)
        • created2013-01-24 10:51:12
        • modified2013-04-17 18:02:40
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id2
        • application_id5
        • sponsorJanssen-Cilag International N.V.
        • sponsor_type(null)
        • contact_personSherry Armstrong-Wilkinson, Clinical Research Africa Limited
        • addressPO Box 422, Karen-00502, Kenya
        • telephone_number+254 702 707 764
        • fax_number
        • cell_number+254 732 452 564
        • email_addresssherry@crafrica.com
        • created2013-01-23 13:22:58
        • modified2013-04-17 18:02:40
  • 1(array)
    • Application(array)
      • id4
      • user_id21
      • trial_status_id4
      • abstract_of_study<p style=\"margin-left:82.8pt;\">\n <u>DESIGN:</u>            This is a prospective, randomized, active-controlled clinical trial.</p>\n<p style=\"margin-left:82.8pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>Step 1:</u> Participants will be randomized 1:1:1 to oral etoposide (ET) plus antiretroviral therapy (ART), bleomycin and vincristine (BV) plus ART, or doxorubicin HCL liposome injection (Doxil^®, PLD) plus ART.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>Step 2:</u> Participants who originally have a Kaposi’s sarcoma (KS) response (complete or partial [CR or PR]) to Step 1 chemotherapy, but then progress at a time <u>point</u> of at least 12 weeks or longer after the last dose of Step 1 chemotherapy, but prior to week 72, may be provided a second course of up to 6 cycles of the same chemotherapy utilized in Step 1. This option is available for study participants who have a confirmed initial KS response and subsequent Independent Endpoint Review Committee (IERC)-confirmed KS progression and who, in the opinion of the investigator and with concurrence of the protocol Clinical Management Committee (CMC) (see Section 7.1 for definition of IERC-confirmed KS progression), could potentially benefit from another course of the same chemotherapy. Participants who have received ET in Step 1 will initiate treatment in Step 2 at the dose last tolerated in Step 1.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>Step 3</u>: Participants will be randomized (1:1) to one of the two chemotherapy arms not utilized in Step 1.  If IERC-confirmed KS progression or chemotherapy-related toxicity occurs in Step 1 or Step 2, participants will be offered alternative study treatment in Step 3. Participants must enter Step 3 within the 72 weeks following Step 1 randomization. Participants will move to Step 3 when (1) there is IERC-confirmed KS progression at any time during Step 1 <u>chemotherapy</u>; or (2) there is IERC-confirmed KS progression less than 12 weeks after the last chemotherapy dose in Step 1 in participants who have had complete or partial response; or (3) there is IERC-confirmed KS progression following Step 1 chemotherapy, without any prior response; or (4) there is IERC-confirmed KS progression in Step 2; or (5) there is dose-limiting toxicity after receiving less than 4 cycles of chemotherapy in Step 1 or Step 2, in the absence of a CR or PR. Participants otherwise eligible for Step 2 who, in the opinion of the investigator and the CMC, are unlikely to benefit from another course of the same chemotherapy received in Step 1 will also be eligible for randomization in Step 3.  If there is IERC-confirmed KS progression in Step 3, participants may enter Step 4 or be offered alternative care available locally outside of the study, whichever the investigator deems most appropriate. If an investigator offers locally-available alternative care, the participants will be followed according to their original Step 3 schedule.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>Step 4</u>: Following CMC and IERC-confirmed KS progression on Step 3, or if there is dose-limiting toxicity after receiving less than 4 cycles of chemotherapy in Step 3, in the absence of a CR or PR, participants will be assigned to the remaining study-provided chemotherapy not given in Step 1, Step 2, or Step 3. Participants must enter Step 4 within the 72 weeks following Step 1 randomization.  If there is IERC-confirmed KS progression in Step 4, participants may be offered alternative care available locally, outside of the study. If an investigator offers locally-available alternative care, the participants will be followed according to their original Step 4 schedule.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>DURATION:</u>       All participants will be followed for 5 years after randomization or assignment to the last step they enter. Therefore, participants could be followed for 5 to 7 years.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>SAMPLE SIZE</u>:  706 participants ≥ 18 years of age</p>\n<p>\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>POPULATION</u>: HIV-infected men and women with the following characteristics:</p>\n<p style=\"margin-left:54.0pt;\">\n  </p>\n<ul>\n <li>\n Biopsy diagnostic of KS</li>\n <li>\n Naïve to ART (as defined in Section 4.2.7), chemotherapy, and radiation therapy</li>\n <li>\n KS stage T1, (See section 4.1.3) </li>\n <li>\n Persons with chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, must have completed at least 14 consecutive days of appropriate anti-infective treatment prior to study entry and be clinically stable</li>\n</ul>\n<p style=\"margin-left:82.8pt;\">\n  </p>\n<p>\n <u>STRATIFICATION</u>:</p>\n<p>\n  </p>\n<ul>\n <li>\n CD4+ lymphocyte cell count < 100 or ≥ 100 cells/mm³</li>\n <li>\n By country</li>\n</ul>\n<p>\n <u>REGIMEN </u></p>\n<p>\n  </p>\n<p style=\"margin-left:118.8pt;\">\n Step 1:</p>\n<p style=\"margin-left:82.8pt;\">\n <u>Arm 1A</u>: Coformulated efavirenz, tenofovir, and emtricitabine (EFV/FTC/TDF) plus ET 50 mg twice a day (with escalation on subsequent cycles up to a maximum of 100 mg twice a day, depending on toxicity) for 7 consecutive days of every 3-week cycle.  Treatment with ET will continue for a maximum of 6 cycles at the highest dose achieved, or until toxicity requiring discontinuation of study chemotherapy, or until the site investigator and A5263/AMC 066 CMC have determined that alternative therapy is required, whichever occurs first.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>Arm 1B</u>: Coformulated EFV/FTC/TDF plus bleomycin 15 units/m² IV (intravenous) plus vincristine 2mg IV every 3 weeks.  Treatment with BV may continue for a maximum of 6 cycles, or until toxicity requiring discontinuation of study chemotherapy, or until the site investigator and the A5263/AMC 066 CMC have determined that alternative therapy is required, whichever occurs first.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n <u>Arm 1C</u>: Coformulated EFV/FTC/TDF plus pegylated liposomal doxorubicin (PLD) 20 mg/m² IV every 3 weeks.  Treatment with PLD will continue for a maximum of 6 cycles, or until toxicity requiring discontinuation of study</p>\n<p style=\"margin-left:82.8pt;\">\n  </p>\n<p style=\"margin-left:82.8pt;\">\n chemotherapy, or until the site investigator and the A5263/AMC 066 CMC have determined that alternative therapy is required, whichever occurs first.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:118.8pt;\">\n Step 2: Coformulated EFV/FTC/TDF plus a second course of up to 6 cycles of the same chemotherapy utilized in Step 1</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:118.8pt;\">\n Step 3: Coformulated EFV/FTC/TDF plus a randomly assigned alternative study-provided chemotherapy regimen</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p style=\"margin-left:118.8pt;\">\n Step 4: Coformulated EFV/FTC/TDF plus the remaining study-provided chemotherapy regimen</p>\n
      • study_title<p>\n A5263/AMC 066 "A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings"</p>\n
      • laymans_summary<p>\n AIDS-related Kaposi’s sarcoma (AIDS-KS) occurs in persons who are coinfected with HIV-1 and human herpesvirus 8 (HHV-8 or KSHV). In areas of the world where access to ART and chemotherapy is limited, and where rates of HIV and KSHV coinfection are higher, AIDS-KS is a more significant contributor to morbidity and mortality in HIV-1 infected persons.</p>\n<p>\n  </p>\n<p>\n Given that ART alone often improves or stabilizes AIDS-KS disease, it is possible that combining ART with chemotherapy might provide improved clinical responses.</p>\n<p>\n  </p>\n<p>\n A5263/AMC 066 is a prospective, randomized, active-controlled clinical trial. Randomization will be stratified by CD4+ lymphocyte cell count and country. The main objective is to compare the clinical efficacy of two regimens, oral Etoposide plus ART and Bleomycin and Vincristine (BV) plus ART, to pegylated liposomal doxorubicin (PLD) plus ART for initial treatment of advanced stage AIDS-KS</p>\n
      • short_titleTreatment of Advanced AIDS-KS in Resource-Limited Settings
      • protocol_noECCT/11/10/04
      • version_no2.0
      • date_of_protocol07-08-2012
      • study_drugbleomycin (B), vincristine (V), oral etoposide (ET), Paclitaxel
      • disease_conditionAIDS-KS (Kaposi’s 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_namebleomycin (B), vincristine (V), oral etoposide (ET), Paclitaxel
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaksudoi@hotmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantAllan K Sudoi
      • declaration_date103-04-2013
      • declaration_principal_investigatorAbraham M Siika, MBChB, MMed, Msc
      • declaration_date203-04-2013
      • placebo_presentNo
      • study_objectives<h2>\n 1.1       Primary Objective</h2>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<p style=\"margin-left:37.45pt;\">\n To compare the clinical efficacy of two regimens, <strong>etoposide (</strong>ET) plus ART and <strong>bleomycin plus vincristine (</strong>BV<strong>)</strong> plus ART, to <strong>paclitaxel</strong> (PTX) plus ART for initial treatment of advanced stage <strong>AIDS-related Kaposi’s sarcoma</strong> <strong>(</strong>AIDS-KS<strong>)</strong>.</p>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<h2>\n 1.2       Secondary Objectives</h2>\n<p>\n  </p>\n<ol>\n <li value=\"NaN\">\n Compare <strong>Kaposi’s sarcoma (</strong>KS<strong>)</strong> tumor response in persons randomized to ET plus ART, BV plus ART, and PTX plus ART.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<ol>\n <li value=\"NaN\">\n Compare measures of quality of life in persons randomized to ET plus ART, BV plus ART, and PTX plus ART.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p>\n Compare the safety and toxicity in persons randomized to ET plus ART, BV plus ART, and PTX plus ART.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p>\n Compare suppression of plasma HIV-1 RNA and changes in CD4+ lymphocyte cell count in persons randomized to ET plus ART, BV plus ART, and PTX plus ART.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p>\n Compare adherence to ART in persons randomized to ET plus ART, BV plus ART, and PTX plus ART.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p>\n Compare the incidence of peripheral neuropathy (PN) and symptomatic peripheral neuropathy (SPN) in persons randomized to ET plus ART, BV plus ART, and PTX plus ART.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p>\n <strong>Evaluate</strong> clinical efficacy of the <strong>remaining regimen</strong> after failure of <strong>the</strong> initial regimen.</p>\n<p style=\"margin-left:72.0pt;\">\n  </p>\n<p>\n Evaluate the relationship between response of KS to therapy and development of KS-associated immune reconstitution inflammatory syndrome (KS-IRIS) with:</p>\n<p style=\"margin-left:54.0pt;\">\n  </p>\n<p style=\"margin-left:115.2pt;\">\n 1    Baseline immunohistochemical markers of viral and cellular gene expression in KS tumors.</p>\n<p style=\"margin-left:98.4pt;\">\n  </p>\n<p style=\"margin-left:115.2pt;\">\n <strong>2</strong>    RNA levels for <strong>Kaposi’s sarcoma herpesvirus (</strong>KSHV<strong>)</strong> genes in tumor biopsies at baseline and during therapy.</p>\n<p style=\"margin-left:194.4pt;\">\n  </p>\n<p style=\"margin-left:115.2pt;\">\n .<strong>3</strong>    Suppression of KSHV viral load.</p>\n<p style=\"margin-left:194.4pt;\">\n  </p>\n<p style=\"margin-left:115.2pt;\">\n <strong>4</strong>    Cellular and humoral markers of immune function and immune activation.</p>\n<p style=\"margin-left:194.4pt;\">\n  </p>\n<p>\n Investigate the relationship between plasma and peripheral blood mononuclear cell (PBMC) KSHV viral load.</p>\n<p style=\"margin-left:194.4pt;\">\n  </p>\n<p>\n Encourage donation of excess biopsy materials to the AIDS and Cancer Specimen Resource.</p>\n<p style=\"margin-left:194.4pt;\">\n  </p>\n<p>\n To assess the risk of secondary leukemia and myelodysplasia after <strong>ET</strong>.</p>\n
      • principal_inclusion_criteria<p>\n <u>Inclusion Criteria Step 1</u></p>\n<ol>\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 Biopsy diagnostic of KS at any time prior to study entry.</li>\n <li>\n Current KS stage T1 using ACTG criteria</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n KS stage T1 is KS with any of the following:</p>\n<ul>\n <li>\n symptomatic tumor-associated edema</li>\n <li>\n tumor ulceration</li>\n <li>\n extensive oral KS (other than flat KS confined to the hard palate)</li>\n <li>\n gastrointestinal KS</li>\n <li>\n KS in any other non-nodal visceral organ (e.g., lung)</li>\n</ul>\n<ol>\n <li value=\"4\">\n A minimum of five indicator KS cutaneous marker lesions plus an additional two lesions greater or equal to 4x4 mm that are accessible for punch biopsy.</li>\n <li>\n CD4+ lymphocyte cell count obtained within 28 days prior to study entry at a DAIDS-approved laboratory.</li>\n <li>\n The following laboratory values obtained within 14 days prior to study entry:</li>\n</ol>\n<ul>\n <li>\n Absolute neutrophil count (ANC) ³ 1000 cells/mm³</li>\n <li>\n Hemoglobin ³ 9 g/dL</li>\n <li>\n Platelet count ³ 100,000/mm³</li>\n <li>\n Estimated creatinine clearance of ≥ 60 mL/min.</li>\n <li>\n AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 ´ ULN</li>\n <li>\n Total bilirubin of < 1.5 X ULN</li>\n</ul>\n<ol>\n <li value=\"7\">\n Cardiac ejection fraction of greater than or equal to 50% obtained within 14 days prior to study entry.</li>\n <li>\n Female study volunteers of reproductive potential (defined as girls who have reached menarche, women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL performed within 24 hours before initiating the protocol-specified medications.� �</li>\n <li>\n All participants must agree <u>not</u> to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</li>\n <li>\n If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable forms of contraceptives will be used simultaneously while receiving protocol-specified medications, and for 6 weeks after stopping the medications</li>\n <li>\n � Men and women age ³ 18 years.</li>\n <li>\n � Ability to swallow oral medications and adequate venous access.</li>\n <li>\n � Karnofsky performance status ≥ 60 within 28 days prior to entry.</li>\n <li>\n � Ability and willingness of participant or legal guardian/representative to provide informed consent.</li>\n</ol>\n<p>\n <u>Inclusion Criteria Step 2</u></p>\n<ol>\n <li>\n Complete or partial response to the chemotherapy regimen used in step 1.</li>\n <li>\n KS progression at a time point greater than 12 weeks after the last dose of Step 1 chemotherapy.</li>\n <li>\n Less than 72 weeks after Step 1 entry.</li>\n <li>\n The following laboratory values obtained within 14 days prior to Step 2 entry:</li>\n</ol>\n<ul>\n <li>\n ANC ≥1,000 cells/mm³</li>\n <li>\n Hemoglobin ≥9.0 g/dL</li>\n <li>\n Platelet count ≥100,000/mm³</li>\n <li>\n Estimated creatinine clearance of ≥ 60 mL/min.</li>\n <li>\n AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 ULN</li>\n <li>\n Total bilirubin of <u><</u> 1.5 X ULN</li>\n</ul>\n<ol>\n <li value=\"5\">\n For participants who received PLD in Step 1, cardiac ejection fraction of greater than 50% obtained within 14 days prior to Step 2 entry.</li>\n <li>\n For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to Step 2 entry.</li>\n <li>\n Karnofsky performance status ≥ 50 within 28 days prior to Step 2.</li>\n <li>\n All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</li>\n</ol>\n<p>\n <u>Inclusion Criteria Step 3</u></p>\n<ol>\n <li>\n Inability to continue on Step 1 or Step 2 due to KS progression OR lack of a CR or PR after receiving less than 4 cycles of chemotherapy in Step 1 or Step 2 because of the development of dose-limiting toxicity.</li>\n <li>\n Less than 72 weeks after Step 1 entry.</li>\n <li>\n The following laboratory values obtained within 14 days prior to Step 3 entry:</li>\n</ol>\n<ul>\n <li>\n ANC ≥1,000 cells/mm³</li>\n <li>\n Hemoglobin ≥9.0 g/dL</li>\n <li>\n Platelet count ≥100,000/mm³</li>\n <li>\n Estimated creatinine clearance of ≥ 60 mL/min.</li>\n <li>\n AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 ULN</li>\n <li>\n Total bilirubin of <u><</u> 1.5 X ULN</li>\n</ul>\n<ol>\n <li value=\"4\">\n For participants who did NOT receive PLD in Step 1 or Step 2, cardiac ejection fraction of greater than 50% obtained within 14 days prior to Step 3 entry.</li>\n <li>\n For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to Step 3 entry.</li>\n <li>\n Karnofsky performance status ≥ 50 within 28 days prior to Step 3 entry.</li>\n <li>\n All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</li>\n</ol>\n<p>\n <u>Inclusion Criteria Step 4</u></p>\n<ol>\n <li>\n Inability to continue on Step 3 due to KS progression OR lack of a CR or PR after receiving fewer than 4 cycles of chemotherapy in Step 3 because of the development of dose-limiting toxicity.</li>\n <li>\n Less than 72 weeks after Step 1 entry.</li>\n <li>\n The following laboratory values obtained within 14 days prior to Step 4 entry:� � � � � �</li>\n</ol>\n<ul>\n <li>\n ANC ≥1,000 cells/mm³.</li>\n <li>\n Hemoglobin ≥9.0 g/dL.</li>\n <li>\n Platelet count ≥100,000/mm³.</li>\n <li>\n Estimated creatinine clearance of ≥ 60 mL/min.</li>\n <li>\n AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 ULN.</li>\n <li>\n Total bilirubin of <u><</u> 1.5 X ULN.</li>\n</ul>\n<ol>\n <li value=\"4\">\n For patients who did NOT receive PLD in Step 1, Step 2 or Step 3, cardiac ejection fraction of greater than 50% obtained within 14 days prior to Step 4 entry.</li>\n <li>\n For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to Step 4 entry.</li>\n <li>\n Karnofsky performance status ≥ 50 within 28 days prior to Step 4 entry.</li>\n <li>\n All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n <u>Exclusion Criteria</u><u> Step 1</u></p>\n<ol>\n <li>\n Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to study entry and/or is not clinically stable.�</li>\n <li>\n Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to entry.</li>\n <li>\n Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial tomography (CAT), that in the opinion of the investigator would exclude bleomycin use.</li>\n <li>\n Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within 14 days prior to study enrollment.�</li>\n <li>\n Grade ≥3 peripheral neuropathy (PN) at entry.</li>\n <li>\n Breastfeeding.</li>\n <li>\n Receipt of ART for more than 28 days immediately prior to entry. ART is allowed within� the 28-day window prior to study entry.</li>\n <li>\n Prior or current systemic or locally administered chemotherapy.</li>\n <li>\n Prior or current radiation therapy.</li>\n <li>\n Prior or current immunotherapy, e.g., interferon alfa.</li>\n <li>\n Corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within the last 30 days prior to study entry. A tapering course of corticosteroids as acute therapy for <em>Pneumocystis carinii</em> pneumonia (PCP) or other conditions is an exception and is allowed.</li>\n <li>\n � Any immunomodulator, HIV vaccine, live attenuated vaccines, or other investigational therapy or investigational vaccine within 30 days prior to study entry.</li>\n <li>\n � Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.</li>\n <li>\n � Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.</li>\n <li>\n Current or anticipated receipt of any of the prohibited medications.</li>\n <li>\n In the opinion of the investigator, any psychological or social condition, or addictive disorder that would preclude compliance with the protocol.</li>\n <li>\n � NYHA (New York Heart Association) Functional Class II-IV heart failure.�</li>\n</ol>\n<p>\n <u>Exclusion Criteria Step 2</u></p>\n<ol>\n <li>\n Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 2 entry and/or is not clinically stable.�</li>\n <li>\n Severe toxicity to the chemotherapy regimen used in Step 1 requiring discontinuation of study chemotherapy.</li>\n <li>\n Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 2 entry.</li>\n <li>\n For patients who have not received bleomycin in Step 1:</li>\n</ol>\n<ul>\n <li>\n Development of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.</li>\n <li>\n Patients with an abnormal CXR or CT scan (which may indicate pulmonary KS) should undergo screening evaluations to rule out an infectious cause, per standard of care. If available, other diagnostic procedures such as bronchoscopy should be considered to confirm the presence or absence of pulmonary KS and/or an infectious agent. These procedures should be completed outside the study. These participants should be excluded if, in the opinion of the investigator, use of bleomycin in Step 2 would be detrimental.</li>\n <li>\n Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 2 entry.�</li>\n</ul>\n<ol>\n <li value=\"5\">\n For patients who received vincristine in Step 1, Grade ≥3 PN at Step 2 entry.</li>\n <li>\n For participants who received PLD in Step 1, NYHA Functional Class II-IV heart failure.</li>\n <li>\n Breastfeeding.</li>\n <li>\n Other concurrent chemotherapy, immunotherapy, or radiotherapy.</li>\n <li>\n Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 2 entry.</li>\n</ol>\n<p>\n <u>Exclusion Criteria Step 3</u></p>\n<ol>\n <li>\n Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 3 entry and/or is not clinically stable.�</li>\n <li>\n Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 3 entry.</li>\n <li>\n For patients who did NOT receive bleomycin in Step 1 or Step 2:</li>\n</ol>\n<ul>\n <li>\n Development of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.</li>\n <li>\n Patients with an abnormal CXR or CT scan (which may indicate pulmonary KS) should undergo screening evaluations to rule out an infectious cause, per standard of care. If available, other diagnostic procedures such as bronchoscopy should be considered to confirm the presence or absence of pulmonary KS and/or an infectious agent. These procedures should be completed outside the study. These participants should be excluded if, in the opinion of the investigator, use of bleomycin in Step 3 would be detrimental.</li>\n <li>\n Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 3 entry.�</li>\n</ul>\n<ol>\n <li value=\"4\">\n For participants who did NOT receive vincristine in Step 1 or Step 2, Grade ≥3 PN at Step 3 entry.</li>\n <li>\n For participants who did NOT receive PLD in Step 1 or Step 2, NYHA Functional Class II-IV heart failure.�</li>\n <li>\n � Breastfeeding.</li>\n <li>\n Other concurrent chemotherapy, immunotherapy, or radiotherapy.</li>\n <li>\n Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 3 entry.</li>\n</ol>\n<p>\n <u>Exclusion Criteria Step 4</u></p>\n<ol>\n <li>\n Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 4 entry and/or is not clinically stable.�</li>\n <li>\n Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 4 entry.</li>\n <li>\n For patients who did NOT receive bleomycin in Step 1, Step 2, or Step 3:</li>\n</ol>\n<ul>\n <li>\n Development of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.</li>\n <li>\n Patients with an abnormal CXR or CT scan (which may indicate pulmonary KS) should undergo screening evaluations to rule out an infectious cause, per standard of care. If available, other diagnostic procedures such as bronchoscopy should be considered to confirm the presence or absence of pulmonary KS and/or an infectious agent. These procedures should be completed outside the study. These participants should be excluded if, in the opinion of the investigator, use of bleomycin in Step 4 would be detrimental.</li>\n <li>\n Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 4 entry.�</li>\n</ul>\n<ol>\n <li value=\"4\">\n For participants who did NOT receive vincristine in Step 1, Step 2, or Step 3: Grade ≥3 PN at Step 4 entry.</li>\n <li>\n For participants who did NOT receive PLD in Step 1, Step 2, or Step 3 NYHA Functional Class II-IV heart failure.�</li>\n <li>\n Breastfeeding.</li>\n <li>\n Other concurrent chemotherapy, immunotherapy, or radiotherapy.</li>\n <li>\n Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 4 entry.</li>\n</ol>\n
      • primary_end_points<p>\n Lack of clinical efficacy” defined as KS progression, death by week 48, entry into an additional step prior to week 48, or loss to follow-up.</p>\n
      • scope_diagnosis1
      • 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>\n Abraham M. Siika MBChB, MMed, MS- Site Leader/ Principal Investigator</p>\n<p>\n Naftali Busakhala- MBChB, MMed- Investigator</p>\n<p>\n Charles Kwobah, MBChB- Medical Officer</p>\n<p>\n Mercy Karoney� MBChB- Medical Officer</p>\n<p>\n Simon Wachira Njuguna, B Pharm, MPSK - Pharmacist of Record</p>\n<p>\n Kipruto Kirwa, BSc, MPH, PhD- Quality Manager</p>\n<p>\n Priscilla Cheruiyot, BScN, MPH- Site Coordinator</p>\n<p>\n Martha Mokaya, BSc, MBA- Data Manager</p>\n<p>\n Wilson Lokitala Ekiru, BSc IT- Assistant Data Manager</p>\n<p>\n Agnes M. Nzioka, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Betty Meli, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Michael Tanui, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Julie Choge -� Recruitment Officer</p>\n<p>\n Dorothy Mwimali -� Recruitment Officer</p>\n<p>\n Cecilia Chebet, Dip Counselling - Recruitment Officer</p>\n<p>\n Beatrice Jakait, B Pharm- Back-up Pharmacist</p>\n<p>\n Zipporah Sambili, Dip Pharm- Back-up Pharmaceutical Technologist</p>\n<p>\n Chris Sande, KHRCN- Study Nurse</p>\n<p>\n �</p>\n
      • other_details_explanation<p>\n Eldoret Kenya is one of the international ACTG sites. When protocols are developed by the ACTG, sites express interests considering the patient population and relevance of the study. Our site expressed interest and one of the investigators Dr. Busakhala was involved in development of this protocol.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Moi Teaching and Referral Hospital/Moi University Institutional Research and Ethics Committee (IREC). Approved on 23 August 2011. Continuing review granted on August 22, 2012</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration All participants will be followed for 5 years after randomization or assignment to the last step they enter. Therefore, participants could be followed for 5 to 7 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorbleomycin and vincristine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states8
      • number_of_sites2
      • multi_country_listBrazil, Peru, Malawi, Zimbabwe, Uganda, Kenya, South Africa, Botswana.
      • data_monitoring_committeeYes
      • total_enrolment_per_site100, Eldoret
      • total_participants_worldwide706
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailabrahamsiika@gmail.com
      • organisations_transferred_No
      • number_participants100 at Eldoret Site. Information on Kericho not immediately available to us
      • notification
      • approval_date07-08-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-08-11 09:27:28
      • created2013-01-22 11:46:37
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id7
        • application_id4
        • given_nameAbraham
        • middle_nameMosigisi
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP O Box, 4606-30100, Eldoret
        • telephone524721280785
        • emailambrahamsiika\"gmail.com
        • created2013-01-25 14:55:21
        • modified2020-08-11 09:27:28
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        • application_id4
        • county_id27
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        • physical_addressAMPATH at MTRH, Nandi Road, Eldoret
        • contact_details+254 53 2060850
        • contact_personAllan Sudoi
        • site_capacity(null)
        • misc(null)
        • created2013-01-25 14:55:21
        • modified2020-08-11 09:27:28
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          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 1(array)
        • id16
        • application_id4
        • county_id35
        • site_nameKEMRI Walter Reed Project
        • physical_addressKericho District Hospital Grounds
        • contact_details0713603225
        • contact_personHellen Ngeno
        • site_capacity(null)
        • misc(null)
        • created2013-01-25 15:21:58
        • modified2020-08-11 09:27:28
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id3
        • application_id4
        • sponsorNational Institutes of Health
        • sponsor_typeOthers
        • contact_person
        • address9000 Rockville Pike Bethesda, Maryland 20892
        • telephone_number301-496-4000
        • fax_number
        • cell_number301-496-4000
        • email_addressNIHinfo@od.nih.gov
        • created2013-01-25 14:55:21
        • modified2020-08-11 09:27:28
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