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      • id425
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      • abstract_of_study<p>\n The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious<br />\n disease threat worldwide. The global incidence of new human immunodeficiency virus (HIV)<br />\n infections peaked in the mid-1990s, and a reduction in this incidence has been observed. In 2012<br />\n there were 2.3 million new cases, down from 3.4 million in 2001. The reduction of HIV<br />\n incidence is due to multiple factors that include prevention and treatment programs. The wider<br />\n availability of antiretroviral therapy (ART), prevention of mother-to-child transmission<br />\n programs, and a diverse array of other interventions have all contributed to turning the tide of the<br />\n epidemic. Long-term use of antiretroviral therapy (ART) in HIV-positive persons may be<br />\n challenged by the need for high-level life long adherence to a daily regimen, development of<br />\n drug resistance and cross-resistance, short and long-term toxicities, and cost. Administration of<br />\n broadly neutralizing monoclonal antibodies has the potential to treat HIV infection by preventing<br />\n viral spread, by facilitating clearance of virus particles and mediating destruction of virusproducing<br />\n cells. This may decrease the viral reservoir and limit chronic immune activation. This<br />\n is a multi-centre, double-blinded, placebo-controlled study of the safety and impact of broadly<br />\n neutralizing monoclonal antibody therapy with VRC01 on viremia in acute HIV infection, alone<br />\n or in combination with antiretroviral therapy (ART). A total of twenty four participants will be<br />\n enrolled, with Kericho site enrolling about six participants. Participants will be randomized to<br />\n three groups; 1, 2 and 3. Group 1 will receive immediate ART only (n=8), Group 2 will receive<br />\n immediate ART and mAb therapy (n=8) and Group 3 will receive immediate mAb therapy and<br />\n subsequent ART from day 7 (n=8). Other sites participating include Uganda, Tanzania and<br />\n Thailand. Participants from the RV217 High Risk Cohort study who become acutely infected<br />\n with HIV will be screened and enrolled into this study. The study duration is 25 weeks. Results<br />\n obtained from this study may inform considerations for the development of broadly neutralizing<br />\n monoclonal antibodies for use in therapeutic settings.</p>\n
      • study_title<p>\n Safety  and  Virologic Effect  Of  A  Human   Monoclonal   Antibody,   VRC-HIVmAb060-00-Ab  (VRCOl),   With Broad  HIV-1  Neutralizing Activity, Administered Intravenously to Adults  During Early Acute HIV Infection.</p>\n
      • laymans_summary<div>\n The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious</div>\n<div>\n disease threat worldwide. The global incidence of new human immunodeficiency virus (HIV)</div>\n<div>\n infections peaked in the mid-1990s, and a reduction in this incidence has been observed. In 2012</div>\n<div>\n there were 2.3 million new cases, down from 3.4 million in 2001. The reduction of HIV</div>\n<div>\n incidence is due to multiple factors that include prevention and treatment programs. The wider</div>\n<div>\n availability of antiretroviral therapy (ART), prevention of mother-to-child transmission</div>\n<div>\n programs, and a diverse array of other interventions have all contributed to turning the tide of the</div>\n<div>\n epidemic. Long-term use of antiretroviral therapy (ART) in HIV-positive persons may be</div>\n<div>\n challenged by the need for high-level life long adherence to a daily regimen, development of</div>\n<div>\n drug resistance and cross-resistance, short and long-term toxicities, and cost. Administration of</div>\n<div>\n broadly neutralizing monoclonal antibodies has the potential to treat HIV infection by preventing</div>\n<div>\n viral spread, by facilitating clearance of virus particles and mediating destruction of virusproducing</div>\n<div>\n cells. This may decrease the viral reservoir and limit chronic immune activation. This</div>\n<div>\n is a multi-centre, double-blinded, placebo-controlled study of the safety and impact of broadly</div>\n<div>\n neutralizing monoclonal antibody therapy with VRC01 on viremia in acute HIV infection, alone</div>\n<div>\n or in combination with antiretroviral therapy (ART). A total of twenty four participants will be</div>\n<div>\n enrolled, with Kericho site enrolling about six participants. Participants will be randomized to</div>\n<div>\n three groups; 1, 2 and 3. Group 1 will receive immediate ART only (n=8), Group 2 will receive</div>\n<div>\n immediate ART and mAb therapy (n=8) and Group 3 will receive immediate mAb therapy and</div>\n<div>\n subsequent ART from day 7 (n=8). Other sites participating include Uganda, Tanzania and</div>\n<div>\n Thailand. Participants from the RV217 High Risk Cohort study who become acutely infected</div>\n<div>\n with HIV will be screened and enrolled into this study. The study duration is 25 weeks. Results</div>\n<div>\n obtained from this study may inform considerations for the development of broadly neutralizing</div>\n<div>\n monoclonal antibodies for use in therapeutic settings.</div>\n
      • short_titleVRC01 Monoclonal HIV Antibodies Study
      • protocol_noECCT/15/10/01
      • version_no2.0
      • date_of_protocol29-04-2015
      • study_drugVRC01 Monoclonal Antibodies
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameNormal Saline
      • comparator_registeredYes
      • comparator_countriesKenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjosphat.kosgei@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr josphat Kosgei
      • declaration_date108-10-2015
      • declaration_principal_investigatorDr Josphat Kosgei
      • declaration_date208-10-2015
      • placebo_presentYes
      • study_objectives<div>\n PRIMARY OBJECTIVES</div>\n<div>\n 1. Safety of VRC01 in acutely HIV-infected viremic individuals</div>\n<div>\n 2. Impact of VRC01 on plasma viremia in each mAb arm compared to the ART plus</div>\n<div>\n placebo control at day 7 (+/- 1 day)</div>\n<div>\n 3.2 SECONDARY OBJECTIVES</div>\n<div>\n 1. Impact of VRC01 on viral dynamics in plasma over the course of 24 weeks.</div>\n<div>\n 2. Impact of VRC01 on HIV reservoir measures in peripheral blood mononuclear cells and</div>\n<div>\n plasma</div>\n<div>\n 3. Impact of VRC01 on clinical outcomes/characteristics of AHI</div>\n<div>\n 4. Impact of VRC01 on CD4 + T cell count</div>\n<div>\n 5. Pharmacokinetics of VRC01 in AHI in peripheral blood</div>\n<div>\n 3.3 EXPLORATORY OBJECTIVES</div>\n<div>\n 1. Impact of VRC01 on reservoir measures in CSF, mucosal, and tissue compartments</div>\n<div>\n 2. Comparison of peripheral blood reservoir measures to those in the CSF, mucosal and</div>\n<div>\n tissue compartments</div>\n<div>\n 3. Impact of VRC01 on reservoir measures in T cell subsets</div>\n<div>\n 4. Pharmacokinetics of VRC01 in CSF and mucosal compartments</div>\n<div>\n 5. Anti-VRC01 antibody detection</div>\n<div>\n 6. Impact of VRC01 on immune responses and activation</div>\n<div>\n 7. Effect of VRC01 on viral sequence, phenotype, and evolution</div>\n<div>\n 8. Predictors of favorable viral dynamics, immune responses, and reservoir seeding</div>\n<div>\n 9. Impact of VRC01 on neuropsychological testing outcomes</div>\n
      • principal_inclusion_criteria<p>\n 1. Able and willing to complete the informed consent process.<br />\n 2. Passes Test of Understanding<br />\n 0 20 40 60 80 100<br />\n 0<br />\n 2<br />\n 4<br />\n 6<br />\n 8<br />\n 10<br />\n Days From First RNA Positive<br />\n VL (log10 cps/ml)<br />\n days to Nadir<br />\n day to EIA<br />\n days to peak<br />\n 42<br />\n 15<br />\n 13<br />\n 4.2<br />\n 6.7<br />\n RV 398/WRAIR 2166 Version 2.0<br />\n 29 April 2015<br />\n Page 26 of 79<br />\n 3. 18 to 50 years of age.<br />\n 4. Experiencing early acute HIV-1 infection as defined by blood samples on at least two<br />\n separate days positive by nucleic acid testing within 21 days of a negative nucleic acid<br />\n HIV-1 test.<br />\n 5. No history of antiretroviral therapy for any indication<br />\n 6. In general good health<br />\n 7. Willing to have blood samples collected and stored.<br />\n 8. Able to participate for 25 weeks for study visits<br />\n 9. Willing to have photo or fingerprint taken for identification purposes<br />\n Female-specific Criteria:<br />\n 10. Agrees not to become pregnant from the time of study enrollment until the last study<br />\n visit. If a woman has no history of hysterectomy, tubal ligation or menopause, she must<br />\n agree to use an effective birth control method: abstinence; male or female condoms;<br />\n diaphragm or cervical cap with spermicide; intrauterine device; contraceptive hormones<br />\n delivered by pills, patch, injections, or vaginally; and hormonal implants under the skin;<br />\n or a male partner who has previously undergone a vasectomy.<br />\n 11. Negative β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day<br />\n of enrollment for any woman unless she is post-menopause for 24 consecutive months or<br />\n has undergone a surgical procedure that precludes pregnancy.</p>\n
      • principal_exclusion_criteria<p>\n Exclusion Criteria<br />\n 1. Weight < 46 kg or >115kg<br />\n 2. Previous receipt of humanized or human monoclonal antibody whether licensed or<br />\n investigational.<br />\n 3. Ongoing AIDS-related opportunistic infection (including oral thrush or active<br />\n tuberculosis).<br />\n 4. Severe acute retroviral syndrome (as defined in Appendix 1) or other clinical condition<br />\n constituting an indication for immediate antiretroviral therapy per local country<br />\n guidelines.<br />\n 5. Active injection drug use within previous 12 months.<br />\n 6. History of a severe allergic reaction with generalized urticaria, angioedema or<br />\n anaphylaxis in the 2 years prior to enrollment.<br />\n 7. History of chronic urticaria<br />\n 8. Physical finding on examination considered indicative of significant disease such as<br />\n murmur (other than functional), hepatosplenomegaly, focal neurological deficit.<br />\n 9. Hypertension that is not well controlled by medication.<br />\n 10. Positive Hepatitis B surface antigen at any time in the past<br />\n RV 398/WRAIR 2166 Version 2.0<br />\n 29 April 2015<br />\n Page 27 of 79<br />\n 11. History of hepatitis C infection<br />\n 12. Untreated syphilis infection<br />\n 13. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper<br />\n limit of normal (ULN).<br />\n 14. Absolute neutrophil count (ANC) <740 cells/mm3<br />\n 15. Estimated GFR < 50 ml/min within the past 90 days<br />\n 16. Breast-feeding.<br />\n 17. Pregnancy<br />\n 18. Receipt of licensed vaccine or other investigational study agent within 28 days prior to<br />\n enrollment or past participation in an investigational HIV vaccine study with receipt of<br />\n active product.<br />\n 19. Current or planned participation in another interventional clinical trial during the study<br />\n period.<br />\n 20. Chronic or recurrent use of medications that modify host immune response, e.g., oral or<br />\n parenteral steroids, cancer chemotherapy.<br />\n 21. Any other chronic or clinically significant medical condition that in the opinion of<br />\n investigator would jeopardize the safety or rights of the volunteer. Including, but not<br />\n limited to: diabetes mellitus type I, chronic hepatitis, renal failure; OR clinically<br />\n significant forms of: drug or alcohol abuse, mental illness, severe asthma, autoimmune<br />\n disease, psychiatric disorders, heart disease, or cancer.<br />\n 22. Study site employee</p>\n
      • primary_end_points<p>\n 1. Safety: mAb related - grade 3 or greater reactogenicity and product related AEs<br />\n <br />\n 2. Log change in plasma viral load from day 0 to day 7</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • 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_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Site Principal Investigator<br />\n Josphat Kosgei,<br />\n MBChB, MSc<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n Mobile phone: 254-729-110122, E-mail: josphat.kosgei@usamru-­â€k.org<br />\n Study Coordinator<br />\n Elizabeth Ngetich,<br />\n BSN<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n E-mail: elizabeth.ngetich@usamru-­â€k.org<br />\n Associate Investigators<br />\n Fredrick Sawe,<br />\n MBChB, MMed.<br />\n Senior Deputy Director,<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n Mobile phone: 254-724-255-623, E-mail: fredrick.sawe@usamru-­â€k.org<br />\n Samuel Sinei,<br />\n MBChB, MMed<br />\n Program Director<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n Mobile phone: 254-727-531-396, E-mail: samuel.sinei@usamru-­â€k.org<br />\n Deborah Chepng’eno<br />\n Langat, MBChB,<br />\n MSc<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n E-mail: Deborah.langat@usamru-­â€k.org<br />\n RV 398b/WRAIR 2166b Page 2 of 4 Version 2.0<br />\n Protocol Team Roster 08 June 2015<br />\n Lucy C. Koech,<br />\n MBChB<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Pharmacy Head, &Hospital Road, P.O. Box 1357, Kericho, 20200;<br />\n Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n Mobile phone: 254-726-290103, E-mail: lucy.koech@usamru-­â€k.org<br />\n Faith Riziki, B.<br />\n Pharm, MSc<br />\n Pharmacist of Record<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Pharmacy Head, &Hospital Road, P.O. Box 1357, Kericho, 20200;<br />\n Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n Mobile phone: 254-726-290103, E-mail: Faith.Riziki@usamru-­â€k.org<br />\n Joseph Oundo, MSc,<br />\n PhD<br />\n Laboratory Director,<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Clinical Research Center Laboratory.<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n E-mail: joseph.oundo@usamru-­â€k.org<br />\n Ignatius Kiptoo, BSc,<br />\n MSc<br />\n Information Technology Department Head.<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n Mobile phone:254-727-531375; E-mail: ignatius.kiptoo@usamru-­â€k.org<br />\n DoD Research Monitors<br />\n Jonah Maswai,<br />\n MBChB, MPH<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n Mobile phone:254-716-430271; E-mail: jonah.maswai@usamru-­â€k.org<br />\n Appolonia Aoko,<br />\n MBChB, MPH<br />\n Kenya Medical Research Institute/Walter Reed Project HIV Program<br />\n Hospital Road, P.O. Box 1357, Kericho, 20200; Kenya<br />\n Office: (254-52) 30686, 30388, Fax: (254-52) 30546<br />\n Mobile phone:254-715-551234; E-mail: appolonia.aoko@usamru-­â€k.org</p>\n
      • other_details_explanation<p>\n The source cohort study for this study is not being carried out in the USA, hence only the countries with the source cohort are participating. Two protocols (VRC 601 and VRC 602) utiling the same experimental product as this study are being carried out in the USA.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n KEMRI. One site in Kenya. Approval date - 21 september 2015.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable.</p>\n
      • estimated_duration25 Weeks
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo, 0.9% Saline
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Walter Reed Project Kericho
      • single_site_physical_addressHospital Road
      • single_site_contact_personDr Josphat Kosgei
      • single_site_telephone+254 729 110 122
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listKenya, Uganda, Tanzania, Thailand
      • data_monitoring_committeeYes
      • total_enrolment_per_site6
      • total_participants_worldwide24
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameC
      • investigator1_family_nameNgetich
      • investigator1_qualificationBSc Nursing
      • investigator1_professional_addressKEMRI/WRP Kericho
      • investigator1_telephone+254 713 603 217
      • investigator1_emailelizabeth.ngetich@usamru-k.org
      • organisations_transferred_Yes
      • number_participants6
      • notification
      • approval_date20-03-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted01-07-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n <strong>To:</strong> The Registrar,</div>\n<div>\n Pharmacy and Poisons Board,</div>\n<div>\n P.O. Box 27663- 00506</div>\n<div>\n NAIROBI. KENYA.</div>\n<div>\n  </div>\n<div>\n <strong>Attn: Expert Committee on Clinical Trials</strong></div>\n<div>\n  </div>\n<div>\n From: Josphat Kosgei, MBChB; MSc, DLSHTM</div>\n<div>\n Principal Investigator PPB/ECCT/15/10/01</div>\n<div>\n KEMRI/WRP HIV Program</div>\n<div>\n P.O Box 1357- 20200 Kericho, Kenya</div>\n<div>\n Tel; 052 5220 36100</div>\n<div>\n Email: Josphat.Kosgei@usamru-k.org</div>\n<div>\n  </div>\n<div>\n <strong>SUBJECT</strong>: Submission of the Study's Close Out Executive Summary Report for ECCT/15/10/01 protocol titled: “Safety and Virologic Effect Of A Human Monoclonal Antibody, VRC-HIVmAb060-00-Ab (VRCOl), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to Adults During Early Acute HIV Infection.’’(RV 398b).</div>\n<div>\n  </div>\n<div>\n The purpose of this memo is to submit the close out executive summary report for the above-mentioned study for PPB/ECCT notification and acknowledgement.</div>\n<div>\n  </div>\n<div>\n <strong>1. INTRODUCTION:</strong></div>\n<div>\n This was a placebo-controlled study of the safety and impact of broadly neutralizing monoclonal antibody (mAb) therapy with VRC01 on viral dynamics in acute HIV infection, alone or in combination with antiretroviral therapy (ART). Subjects were enrolled during early acute HIV infection (AHI): defined as two positive nucleic acid amplification tests (NAATs) for HIV-1 RNA within 21 days of a prior negative NAAT. They were randomized to one of three groups:</div>\n<div>\n • Group 1, Immediate ART and placebo infusion (n=8): start ART with a single infusion of placebo on day 0 during AHI .</div>\n<div>\n • Group 2, Immediate ART and mAb Therapy (n=8): start ART with a single infusion of 40 milligrams/kilograms (mg/kg) VRC01 on day 0 during AHI</div>\n<div>\n • Group 3, Immediate mAb Therapy and Subsequent ART (n=8): a single infusion of 40 mg/kg VRC01 on day 0 during AHI followed by ART initiation on day 7</div>\n<div>\n  </div>\n<div>\n <strong>2. RESEARCH OBJECTIVES:</strong></div>\n<div>\n a) <strong>Primary Objective</strong></div>\n<div>\n 1. Safety of VRC01 in acutely HIV-infected individuals.</div>\n<div>\n 2. Impact of VRC01 on plasma viremia in each mAb arm compared to the ART plus placebo control at day 7 (+/- 1 day).</div>\n<div>\n 3. <strong>SUMMARY OF STUDY RESULTS:</strong></div>\n<div>\n For groups 1 and 2, participants and study team were blinded to active mAb vs. placebo infusion. After day 7, all groups were on ART and followed for 24 weeks.</div>\n<div>\n US Army Medical Research Directorate-Africa</div>\n<div>\n From 11 December 2016 to 31 May 2018, fifteen subjects were enrolled in RV398 at 3 sites in East Africa and 1 site in Thailand. All fifteen have completed their follow-up. RV217, the source protocol for recruiting acutely HIV-infected participants into RV398, was closed on 30 September 2018. No further study activities have since occurred at the East African sites. From 01 June 2018 to 12 February 2020, there were no enrollments into RV398 as the protocol was modified to recruit acutely HIV-infected participants enrolling in RV254 and to add a new study site, South East Asia Research Collaboration in HIV (SEARCH) Clinic, Thai Red Cross AIDS Research Center (TRCARC), Bangkok, Thailand. Since 13 February 2020 when enrollment began at SEARCH, nine participants have been enrolled into RV398.</div>\n<div>\n The study has now enrolled 24 of the 24 subjects permitted by the protocol. With the onset of the COVID-19 outbreak, the SEARCH team adopted enhanced infection prevention and control measures to mitigate risk and allow for continued low volume enrollment in the RV254 source cohort and in RV398 while pausing optional invasive procedures for study participants.</div>\n<div>\n In Kenya Kericho, the site was originally approved to enroll 6 participants. 6 participants were enrolled, and all participants completed all study activities.</div>\n<div>\n Infusions have been well tolerated. A summary of the data and adverse events for the overall study was just reviewed by the Safety Monitoring Committee (SMC) in the 13 January 2021 SMC Report (Attached).</div>\n<div>\n The cumulative deviation log, which includes all major and minor deviations that occurred in the study, is attached herein and the same have been uploaded on the ECCT portal.</div>\n<div>\n 4. List publications arising from study (attach copies of the manuscript(s).</div>\n<div>\n A summary of the data and adverse events for the overall study was reviewed by the Safety Monitoring Committee (SMC) in the 13 January 2021 and 13 July 2020 SMC Reports Attached herein.</div>\n<div>\n 5. Confirm destruction of each study participant’s identifiers and provide an assurance/evidence that the destruction has occurred (send copies of the blacked-out books).</div>\n<div>\n Data obtained from the conduct of this study are housed in a secure database maintained by the DCAC, MHRP, WRAIR. DCAC serves as the central data management facility for MHRP research protocols. Data managed by DCAC are entered into and maintained in a password-protected database accessible only to participating sites, DCAC and Information Technology staff authorized to work on the protocol. The database is located at the Bethesda campus of MHRP and is protected by a firewall. This data does not contain participant names or national identification number, but is referenced only by the study identification number. The clinical database is currently locked, and DCAC will maintain it indefinitely or until there is a regulatory requirement or sponsor instructions to destroy it. At the Kericho site the PI maintained research records of participants’ participation for this study. All participants received study numbers that were known only to the investigators and clinic staff. Clinical tests were identified by the study number and the specimen bag was identified by the study number and bar code only. The subject ID does not contain any identifiable information or any information which can be used to identify a study participant either directly or indirectly. These identification numbers were used for medical records, all laboratory tests or samples stored for testing in future studies. The study participants’ medical records were stored at the Clinical Research Center (CRC) archive room which is access controlled and double locked. The study documents have now been transferred to a safe, secured, long-term archive room within the Kericho CRC that is only accessible to regulatory personnel. All other research staff do not have access to this archive room. Destruction approval will be obtained from the sponsor and the IRBs will be notified when this is done. Any publication of this study will not use the study participant’s name or identify him/her personally. Efforts will be made to keep the study participants’ personal information confidential. The personal information may be disclosed if required by law. Clinical and research records may be reviewed by the representative of the KEMRI SERU, DAIDS, USAMRMC, WRAIR, representatives of the USAMRMC ORP,</div>\n<div>\n US Army Medical Research Directorate-Africa</div>\n<div>\n representatives of the FDA, OHRP, the product and device providers, and other regulatory agencies as part of their responsibilities for insuring the protection of research participants. Every effort will be made to keep the records as confidential as possible within the limits of the law. All data and medical information obtained about participants, as individuals will be considered privileged and held in confidence. Identification photographs did not contain participants’ names, but only a four-digit Study Number. A file copy of the photograph was kept in a secure location with other study documents and was only accessible to study staff. Research and clinical information relating to participants was shared with other investigators and the scientific community through presentation or publication; however, participants were NOT identified by name or social security number. Electronic data will be stored at least as long as the IND remains open. All participants received an emergency card indicating their status as a clinical trial participant. All participants were counseled periodically regarding the potential for testing positive on routine screening tests for HIV-1 as a consequence of participation in this trial and receiving this vaccine product. All participants were offered further confirmatory testing and certification as to the nature of their vaccine trial participation whenever needed to address complications arising at home, at work, or in the community, which could arise from routine screening for HIV.</div>\n<div>\n 6. Destruction of each study participant’s identifiers and provide an assurance/evidence that the destruction has occurred (send copies of the blacked-out books).</div>\n<div>\n Study documents have been transferred to a safe, secured, long-term archive room that is only accessible to two regulatory personnel. All other research staff does not have access to this archive room. Access to study documents is controlled and restricted and the site is responsible for ensuring that any access is accurately recorded and any documents accessed/removed and returned are recorded. Destruction approval will be obtained from the sponsor and the IRBs will be notified when this is done.</div>\n<div>\n 7. Plan for future use of data from the study (if applicable)</div>\n<div>\n All work for this study is complete. There are no future plans and any future use of individually coded data will have to be approved by the IRB. No further use of specimens or data can occur until a new protocol is approved and authorized by the WRAIR Institutional Review Board (IRB) and KEMRI SERU.</div>\n<div>\n 8. Confirm destruction of surplus investigational agents and provide an assurance/evidence that the destruction has occurred (if applicable).</div>\n<div>\n Attached is RV 398 Investigation Products Destruction Authorization Documents.</div>\n<div>\n 9. Detail the plan for the destruction, storage, or future use of biological specimens obtained as part of this study (include number of samples being destroyed or stored).</div>\n<div>\n All the samples that were not for safety testing were shipped out with the approval Scientific and Ethics Review Unit for analysis. The site is not storing any study samples</div>\n<div>\n  </div>\n<div>\n <strong>Find below the summary.</strong></div>\n<div>\n US Army Medical Research Directorate-Africa</div>\n<div>\n RV 398 -Sample Shipment</div>\n<div>\n Aliquot type</div>\n<div>\n Quantity</div>\n<div>\n Lymph Node fixed</div>\n<div>\n 11</div>\n<div>\n Rectal BX Fixed</div>\n<div>\n 6</div>\n<div>\n CSF Large Cells</div>\n<div>\n 15</div>\n<div>\n CSF Small Cells</div>\n<div>\n 48</div>\n<div>\n CSF Supernatant</div>\n<div>\n 246</div>\n<div>\n PBMC</div>\n<div>\n 294</div>\n<div>\n Plasma</div>\n<div>\n 387</div>\n<div>\n Recatal Bx VRC01 Lv1</div>\n<div>\n 2</div>\n<div>\n REctal Bx RNA Later</div>\n<div>\n 32</div>\n<div>\n Rectal Bx VRC01 Lv1</div>\n<div>\n 4</div>\n<div>\n Rectal Sponge</div>\n<div>\n 19</div>\n<div>\n Serum</div>\n<div>\n 151</div>\n<div>\n Soft Cup</div>\n<div>\n 61</div>\n<div>\n TOTAL</div>\n<div>\n 1276</div>\n<div>\n  </div>\n<div>\n Thank you for your time and review.</div>\n<div>\n  </div>\n<div>\n <strong>Included in this submission are the following:</strong></div>\n<div>\n a) Initial ECCT approval letter dated 08 January 2016.</div>\n<div>\n b) ECCT annual approval letter dated 22 January 2021.</div>\n<div>\n c) Safety Monitoring Committee (SMC) Report Dated 13 January 2021.</div>\n<div>\n d) Safety Monitoring Committee (SMC) Report Dated 13 July 2021.</div>\n<div>\n e) WRAIR# 2166B Closeout Acceptance Memo Dec 2020.</div>\n<div>\n f) KEMRI SERU#3096 Closeout Acceptance Memo dated 03 May 2021.</div>\n<div>\n g) Cumulative Deviation Log.</div>\n<div>\n h) RV 398 Investigation Products Destruction Authorization Documents.</div>\n<div>\n  </div>\n<div>\n The point of contact for this action is <strong>Dr. Josphat Kosgei</strong> at the Kenya Medical Research Institute-US Army Medical Research Directorate-Africa, who can be reached by email at <strong>josphat.kosgei@usamru-k .org.</strong></div>\n<div>\n  </div>\n<div>\n  </div>\n
      • implication_results<p>\n  </p>\n<p>\n <span style=\"font-size:14px;\">Yes,VRC01 intervention during early acute HIV infection was seen to be well tolerated and thus to ensure and determine whether it could significantly play a vital role in viral suppression, it may be imperative to encourage further development of it together with other immunotherapies for HIV directed against unique therapeutic targets.</span></p>\n
      • quantity_imported1. VRC-HIVmAb060-00-Ab (VRCOl) = 80 (2) 0.9%Sodium Chloride Inj USP 50ml = 24
      • quantity_dispensed1. VRC-HIVmAb060-00-Ab (VRCOl) = 45 (2) 0.9%Sodium Chloride Inj USP 50ml = 2
      • quantity_destroyed1. VRC-HIVmAb060-00-Ab (VRCOl) = 35 (2) 0.9%Sodium Chloride Inj USP 50ml = 22
      • quantity_exported1. VRC-HIVmAb060-00-Ab (VRCOl) = 0 (2) 0.9%Sodium Chloride Inj USP 50ml = 0
      • balance_site1. VRC-HIVmAb060-00-Ab (VRCOl) = 0 (2) 0.9%Sodium Chloride Inj USP 50ml = 0
      • final_date0000-00-00
      • modified2024-12-17 15:41:52
      • created2015-10-07 16:37:05
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id288
        • application_id425
        • given_nameJosphat
        • middle_nameK
        • family_nameKosgei
        • qualificationMBChB, MSc, DLSHTM.
        • professional_addressKEMRI/WRP Kericho
        • telephone+254 729 110 122
        • emailjosphat.kosgei@usamru-k.org
        • created2015-10-07 16:41:59
        • modified2020-07-01 11:51:32
    • SiteDetail(array)
      • 0(array)
        • id342
        • application_id425
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-10-07 16:41:59
        • modified2020-07-01 11:51:32
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id225
        • application_id425
        • sponsorNational Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), National Institutes of Health (NIH) Bethesda, Maryland
        • sponsor_typeOthers
        • contact_personJulie Ake
        • address6720A Rockledge Drive, Suite 400 Bethesda, MD 20817
        • telephone_number301-500-3621
        • fax_number
        • cell_number240-506-1915
        • email_addressjake@hivresearch.org
        • created2015-10-07 16:41:59
        • modified2020-07-01 11:51:32
  • 1(array)
    • Application(array)
      • id409
      • user_id73
      • trial_status_id5
      • abstract_of_study<p style=\"text-align: justify;\">\n Our objective is to study effects of a contraceptive vaginal ring (CVR) containing estrogen and progesterone (NuvaRing) on vaginal bacteria, HIV shedding, and local immunity in women. We will build on data that support a favorable effect of CVR on vaginal bacteria. Bacterial vaginosis (BV) is found in <u>></u>50% of women in sub-Saharan Africa. BV significantly increases risk of HIV acquisition in, and HIV transmission to male partners from, HIV-infected women, genital HIV shedding, and viral set point in infected male partners. Pregnancy is also an independent risk for HIV acquisition and transmission. Contraception comprises critical biomedical prevention for women with or at risk for HIV. Systemic depot progesterone—commonly used throughout Africa—may independently increase risk of HIV acquisition and transmission. Hormonal interventions preventing unintended pregnancy and promoting a protective vaginal microenvironment could synergistically reduce HIV risk especially combined with topical antiretrovirals (ARV). We hypothesize NuvaRing use may contribute to reduction in BV, pregnancy prevention, and decreased rates of HIV shedding in HIV-infected women. <u>Sustained vaginal delivery of contraceptive and ARV PrEP as “multicomponent prevention” is a major focus for scientists but effects on the vaginal environment need careful definition before broad implementation</u>.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 1: Determine effect of CVR on vaginal bacteria, including incident/persistent BV. </strong>Show whether sustained local hormone delivery promotes desirable lactobacilli, and thus reduces risk of BV, in women with and without HIV.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 2. Define the soluble mucosal host immune response and endocervical immune cell populations with CVR. </strong>Determine if shifts in vaginal bacteria anticipated to occur with CVR will be accompanied by favorable changes in the lower genital tract, including restoration of protective mediators decreased with BV.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 3. In HIV-infected women, determine effect of CVR on genital HIV shedding. </strong>HIV-infected women not on ART at enrollment will have endocervical swabs collected for HIV RNA quantification.</p>\n<p style=\"text-align: justify;\">\n <strong>Study Site and Population</strong></p>\n<p style=\"text-align: justify;\">\n This study will be conducted at the Thika Partners Study Clinic located in Thika, Kenya. We will enroll approximately 120 women with bacterial vaginosis (BV) based on clinical criteria and a minimum of 75 male sex partners.</p>\n
      • study_title<p align=\"center\">\n <strong>Effects of contraceptive ring on vaginal microbiota, HIV shedding and local immunity</strong></p>\n
      • laymans_summary<p>\n The need for contraceptive options in women at risk for HIV acquisition has taken on urgency with evidence indicating that systemic hormonal contraception (primarily injectable, long-acting progestin) may increase women’s risk of HIV acquisition and transmission to male sex partners.<a href=\"#_ENREF_1\" title=\"Polis, 2013 #1991\">¹</a> Lack of other contraceptive options, especially for women at highest risk of HIV in Sub-Saharan Africa, is a critical barrier to progress towards optimizing women’s reproductive health. While intrauterine devices (IUDs) are an option, implementation of delivery has been slow. The use of a contraceptive vaginal ring (CVR) has been explored and reported on in several Sub-Saharan African countries, and its acceptability in general is excellent.<a href=\"#_ENREF_2\" title=\"van der Straten, 2012 #3050\">²</a> A commonly used CVR in the United States is the NuvaRing. Moreover, the format of drug delivery through the form of a vaginal ring is also being intensely explored with the use of antiretroviral agents (dapivirine, tenofovir) as a means of topical, female-controlled HIV prevention, and formulation work with several antiretroviral drugs for sustained delivery with the NuvaRing format is underway.<a href=\"#_ENREF_3\" title=\"Kiser, 2012 #3052\">³</a> Such “multicomponent prevention” has become a major focus for scientists, advocates, and funders alike.</p>\n<p>\n  </p>\n
      • short_titleNuvaRing Study
      • protocol_noECCT/15/09/01
      • version_no2.4
      • date_of_protocol23-06-2015
      • study_drugNuvaRing (Vaginal contraceptive ring)
      • disease_conditionVaginal Bacteria, HIV & Vaginal local Immunity
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameEstrogen & Progesterone
      • product_type_medical_device_nameContraceptive Vaginal Ring (NuvaRing)
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_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_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Kenneth Ngure
      • declaration_date102-09-2015
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date202-09-2015
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objective:</strong></p>\n<p>\n To assess potential benefits associated with both cyclic (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women (both HIV-negative and HIV-positive) with BV at enrollment (and thus at high risk for BV persistence and recurrence).</p>\n<p>\n <strong>Secondary objectives: </strong></p>\n<ol style=\"list-style-type:lower-roman;\">\n <li>\n To determine the effect of the CVR on clinically defined incidence of BV, the vaginal microbiome and rates of adverse events with CVR use.</li>\n <li>\n To assess the acceptability of the CVR to men who are sex partners of study participants.</li>\n <li>\n To assess acceptability and preference for contraceptive type at study end.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong>Female Eligibility Criteria:</strong></p>\n<ul>\n <li>\n ≥18-40 year old BV+ by Amsel’s criteria</li>\n <li>\n Not intending or wishing to become pregnant over the course of the study</li>\n <li>\n Capable of providing written informed consent</li>\n</ul>\n<div>\n  </div>\n<p>\n <strong>Male Eligibility Criteria:</strong></p>\n<ul>\n <li>\n Main sex partner of randomized female participant</li>\n <li>\n Capable of providing written informed consent</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong>Female Exclusion Criteria:</strong></p>\n<ul>\n <li>\n Current pregnancy</li>\n <li>\n Desire/intent to become pregnant over the course of the study</li>\n <li>\n Current cigarette smoking if age is older than 35 years</li>\n <li>\n Unable to comprehend consent material because of language barrier or psychological difficulty</li>\n</ul>\n<p>\n <strong>Male Exclusion Criteria:</strong></p>\n<ul>\n <li>\n Unable to comprehend consent material because of language barrier or psychological difficulty</li>\n</ul>\n
      • primary_end_points<p style=\"margin-left:.5in;\">\n Outcome 1:  Quantity of <em>L. crispatus</em> determined by species-specific qPCR assay</p>\n<p style=\"margin-left:.5in;\">\n Outcome 2:  Local immune parameters, including cytokines, innate mediators, and functional antimicrobial activity in cervicovaginal secretions as assessed                        by anti-<em>E. coli</em>, anti-HSV, and anti-HIV activity</p>\n<p style=\"margin-left:.5in;\">\n Outcome 3:  Quantity of genital HIV shedding among HIV-infected participants </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Elizabeth Irungu  MBChB</p>\n
      • other_details_explanation<p>\n The need for contraceptive options in women at risk for HIV acquisition has taken on urgency with evidence indicating that systemic hormonal contraception (primarily injectable, long-acting progestin) may increase women’s risk of HIV acquisition and transmission to male sex partners.Lack of other contraceptive options, especially for women at highest risk of HIV in Sub-Saharan Africa, is a critical barrier to progress towards optimizing women’s reproductive health. While intrauterine devices (IUDs) are an option, implementation of delivery has been slow. The use of a contraceptive vaginal ring (CVR) has been explored and reported on in several Sub-Saharan African countries, and its acceptability in general is excellent.<span style=\"font-size: 10px;\"> </span>A commonly used CVR in the United States is the NuvaRing. Moreover, the format of drug delivery through the form of a vaginal ring is also being intensely explored with the use of antiretroviral agents (dapivirine, tenofovir) as a means of topical, female-controlled HIV prevention, and formulation work with several antiretroviral drugs for sustained delivery with the NuvaRing format is underway.<span style=\"font-size: 10px;\"> </span>Such “multicomponent prevention” has become a major focus for scientists, advocates, and funders alike.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Washington Institutional Review Board (UW IRB)</p>\n<p>\n Submission will be done before end of September 2015</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute's (KEMRI) Scientific, Ethics and Research Unit (SERU)</p>\n<p>\n                     Approved on 20th July 2015.</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration5 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThika Partners Study Clinic (Partners in Health Research and Development) affiliated to the University of Washington International Clinical Research Center (ICRC), and KEMRI
      • single_site_physical_addressOAU Road, Near Thika Nursing Home
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone067-2222561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site195
      • total_participants_worldwide195
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJeanne
      • investigator1_middle_name
      • investigator1_family_nameMarrazzo
      • investigator1_qualificationProfessor of Medicine
      • investigator1_professional_addressUniversity of Washington, Seattle
      • investigator1_telephone+1-206-744-3679
      • investigator1_emailjmm2@u.washington.edu
      • organisations_transferred_Yes
      • number_participants120 women with bacterial vaginosis (BV) and a minimum of 75 male sex partners.
      • notification
      • approval_date16-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-06-15 11:42:25
      • created2015-07-28 16:22:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id279
        • application_id409
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
    • SiteDetail(array)
      • 0(array)
        • id332
        • application_id409
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id217
        • application_id409
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067 22561
        • fax_numbern/a
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
  • 2(array)
    • Application(array)
      • id413
      • user_id63
      • trial_status_id6
      • abstract_of_study<p>\n Background: Tuberculosis (TB) is one of the most important global health problems. According to recent estimates from the World Health Organization (WHO), 8.6 million new cases and 1.3 million deaths from TB occurred in 2012.  The vast majority of TB cases and TB deaths are in developing countries. The spread of HIV has fuelled the TB epidemic, and TB is the leading cause of death among patients infected with HIV. The national case notification rate is 283/100000, whilst in KisumuCounty, the rate is 317 /100 000.TB treatment takes 6 months in Kenya and this relatively long treatment is associated with high relapse rates, relatively poor compliance than if the regimen were shorter. It is essential to shorten the treatment further, with efficacy proven in the new regimen. Treatment adherence is critical in TB treatment success and a shorter regimen may improve adherence. This study aims to find out the safety, tolerability and efficacy of 2 treatment regimens versus the standard drug susceptible TB treatment regimen currently used in Kenya. This, multicentre, randomized, controlled, open-label, (3-arm, phase 3 non-inferiority) clinical trial will enrol smear positive participants in Kisumu County. They will be randomized into either of the following 3 treatment arms; 2 RHZE/4HR for 26 weeks, 2PHZE/4PH for 17 weeks, 2PHZM/4PHM for 17 weeks. A shorter, more tolerable, efficacious treatment regimen will lead to better compliance, reduce pill burden and drug toxicity whilst improving TB treatment outcomes. </p>\n
      • study_title<p>\n  <span style=\"font-size: 12px;\">Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: a randomized, open-label, controlled, phase 3 clinical trial</span></p>\n
      • laymans_summary<div>\n This stud is a Rifapentine-Containing Treatment shortening regimens for pulmonary tuberculosis, A randomized, open-label, controlled phase 3 clinical trial in</div>\n<div>\n Kisumu County. It is an international, multicenter, randomized, controlled, open-label, 3-arm, phase 3 noninferiority trial. This study will be conducted in various TBTC and ACTG sites across the world In Kenya it will be conducted at the KEMRI/CDC clinical research center at the Jaramogi Oginga Odinga Teaching and referral hospital.</div>\n
      • short_titleRifapentine During Intensive Phase TB Treatment
      • protocol_noECCT/15/08/01
      • version_no1.1
      • date_of_protocol24-11-2014
      • study_drugRifapentine
      • disease_conditionTB
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameRifapentine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressEokeyo@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Elisha Okeyo
      • declaration_date108-08-2015
      • declaration_principal_investigatorDr Kevin P Cain
      • declaration_date208-08-2015
      • placebo_presentNo
      • study_objectives<div>\n PRIMARY OBJECTIVES:</div>\n<div>\n ï‚· To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single</div>\n<div>\n substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the</div>\n<div>\n duration of treatment for drug-susceptible pulmonary tuberculosis</div>\n<div>\n ï‚· To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes</div>\n<div>\n moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to</div>\n<div>\n determine whether it is possible to reduce to seventeen weeks the duration of treatment for</div>\n<div>\n drug-susceptible pulmonary tuberculosis</div>\n<div>\n  </div>\n<div>\n Secondary Objectives</div>\n<div>\n ï‚· To evaluate the safety of the investigational regimens</div>\n<div>\n ï‚· To evaluate the tolerability of the investigational regimens</div>\n<div>\n ï‚· To collect and assess biospecimens from consenting participants for the purpose of</div>\n<div>\n research on discovery and validation of TB biomarkers</div>\n<div>\n ï‚· To determine the correlation of mycobacterial and clinical markers with time to culture</div>\n<div>\n conversion, culture status at completion of eight weeks of treatment, treatment failure,</div>\n<div>\n and relapse.</div>\n<div>\n ï‚· To conduct a pharmacokinetic/pharmacodynamic (PK/PD) study of the test drugs. The</div>\n<div>\n main objectives of the PK/PD study are to characterize study drug PK parameters and</div>\n<div>\n to determine relationships between treatment outcomes and PK parameters.</div>\n<div>\n ï‚· To evaluate the pharmacokinetics of efavirenz-based antiretroviral treatment among</div>\n<div>\n patients with TB/HIV co-infection taking efavirenz-based combination antiretroviral</div>\n<div>\n therapy and TB treatment with rifapentine</div>\n
      • principal_inclusion_criteria<h2>\n <strong>  </strong><strong>Inclusion Criteria</strong><strong>:</strong></h2>\n<p>\n Individuals must meet all of the following inclusion criteria in order to participate in this study:</p>\n<p style=\"margin-left:.75in;\">\n 1)      Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for <em>M. tuberculosis</em> by Xpert MTB/RIF testing, with semi quantitative result of ‘medium’ or ‘high’ and rifamycin resistance not detected. </p>\n<p style=\"margin-left:.75in;\">\n 2)      Age twelve (12) years or older</p>\n<p style=\"margin-left:.75in;\">\n 3)      A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.</p>\n<p>\n 4)      Women of child-bearing potential who are not surgically sterilized must agree to practice a barrier method of contraception or abstain from heterosexual intercourse during study drug treatment.</p>\n<p>\n 5)      Documentation of HIV infection status.</p>\n<p>\n 6)      For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells/mm³ based on testing performed at or within 30 days prior to screening.</p>\n<p>\n 7)      Laboratory parameters done at or within 14 days prior to screening:</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Serum or plasma potassium level greater than or equal to 3.5 meq/L</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Hemoglobin level of 7.0 g/dL or greater</p>\n<p style=\"margin-left:1.5in;\">\n ·                     Platelet count of 100,000/mm³or greater</p>\n<p style=\"margin-left:.75in;\">\n 8)      For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening.</p>\n<p style=\"margin-left:.75in;\">\n 9)      Karnofsky score greater than or equal to 60</p>\n<p>\n 10)  Written informed consent</p>\n<p>\n The study will provide study participants with counselling on the importance of contraception. Participants will be provided for with condoms and those who need other forms of barrier contraception will be referred to the appropriate care givers prior to starting study treatment.</p>\n<h2>\n  </h2>\n
      • principal_exclusion_criteria<h2>\n <strong> </strong><strong>E</strong><strong>xclusion Criteria</strong><strong>:</strong></h2>\n<p style=\"font-size: 11.9999990463257px;\">\n 1)      Pregnant or breast-feeding</p>\n<p style=\"font-size: 11.9999990463257px;\">\n 2)      Unable to take oral medications</p>\n<p style=\"font-size: 11.9999990463257px;\">\n 3)      Previously enrolled in this study</p>\n<p style=\"font-size: 11.9999990463257px;\">\n 4)      Received any investigational drug in the past 3 months</p>\n<p style=\"font-size: 11.9999990463257px;\">\n More than five (5) days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 5)      More than five (5) days of systemic treatment with any one or more of the following drugs within 30 days preceding initiation of study drugs: isoniazid, rifampin, rifabutin, rifapentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin, capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 6)      Known history of prolonged QT syndrome. Site clinicians will assess participants and if there are signs and symptoms of heart disease or suggesting arrhythmias, then the clinician will request for  an ECG to rule out prolonged QT syndrome.</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 7)      Suspected or documented tuberculosis involving the central nervous system and/or bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 8)      Current or planned use within six months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than efavirenz, quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine. Individuals who are currently taking efavirenz-based antiretroviral treatment or for whom initiation of efavirenz-based antiretroviral treatment is planned within 17 weeks following enrollment may participate, as per Section 8.3.10. </p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 9)      Weight less than 40.0 kg</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 10)  Known allergy or intolerance to any of the study medications</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 11)  Individuals will be excluded from enrollment if, at the time of enrollment, their <em>M. tuberculosis</em> isolate is already known to be resistant to any one or more of the following:  rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 12)  Other medical conditions, that, in the investigator’s judgment, make study participation not in the individual’s best interest.</p>\n<p style=\"font-size: 11.9999990463257px; margin-left: 0.75in;\">\n 13)  Current or planned incarceration or other involuntary detention.</p>\n<h2>\n  </h2>\n<p style=\"font-size: 11.9999990463257px;\">\n For minors, less than 18 years of age who are found to be pregnant, then the results of the pregnancy test shall be discussed with the minor as well as the parent. For those minors who already have children, the will be considered as mature minors and the parents will not have to be informed of the results.</p>\n
      • primary_end_points<p>\n <strong>Primary outcome Measure</strong></p>\n<p>\n Proportion of participants with grade 3 or higher adverse events during study drug treatment</p>\n<h3>\n secondary outcome measure</h3>\n<p>\n Discontinuation of assigned treatment for a reason other than microbiological ineligibility</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n STAFF IN THIS STUDY: 3 MEDICAL DOCTORS, 2 PHARMACISTS, 3 FULL-TIME NURSES, 1 PART TIME NURSE, 1 CO-ORDINATOR, 2 COMMUNITY MOBILISATION OFFICER, 1 QA MANAGER,1 OFFICERS, 1 QC OFFICER, 1 DATA MANAGER, 1 DATA OFFICER, 1 DATA SPECIALIST.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n SITE FACILITIES: CLINICAL TRIALS PHARMACY, BIO-SAFETY LEVEL 2 AND 3 TB LABORATORIES, LABORATORY FOR SAFETY PROFILE, ARRANGEMENT FOR IN AND OUT-PATIENT FACILITIES AT NEW NYANZA PROVINCIAL GENERAL HOSPITAL</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u><strong>Profiles of key staff in TB Branch at KEMRI/CDC:</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u><strong>Dr Elisha Okeyo</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u><strong>Position Principal Investigator</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <span style=\"color: rgb(34, 34, 34); font-family: Arial, Verdana, sans-serif; font-size: 12px;\">Dr Elisha currently holds a degree in Medicine.  Prior to joining KEMRICDC, Dr Elisha worked as a resident Medical Officer – Aga khan Hospital Kisumu from  2008 – 2010.  He then joined KEMRICDC as a Junior Investigator TBTC, KEMRI/CDC TB Research Branch       from 2011- 2013. He has been the  study Coordinator TBTC study 29X “Evaluation of a Rifapentine containing regimen for Intensive phase treatment of Pulmonary Tuberculosis in Adults in Kisumu County” and  Co-PI TBTC study 36” Platform for assessment of TB treatment outcomes in Kisumu County”.  Currently he is Co-PI A5279 “phase III clinical trial of ultra-short-course rifapentine/isoniazid for prevention of active tuberculosis in HIV infected individuals with latent tuberculosis infection” He is also a member of Kenya medical Association and Kenya medical Practioners and Dentists board</span></p>\n<p>\n <u>Dr Samuel Gurrion Ouma Ngaywa</u></p>\n<p>\n Position Coordinating PI</p>\n<p>\n Dr OUma is a Medical Doctor and Epidemiologist with 10 years clinical experience and 5 years clinical research experience. He has a Bachelors degree in Medicine and Bachelors degree in Surgery ( MbCHB)  from the University of Nairobi  and  a Masters in Public Health ( Epidemiology) – MPH from the University of Liverpool. He is a Principal investigator in 2 studies in KEMRI CGHR and a Co Investigator in numerous studies in KEMRI CGHR.</p>\n<p>\n His current responsibilities are : Administering protocol training to staff, leading studies as a Principal Investigator and Co Principal Investigator, supervising staff in a research setting and clinical setting, ensuring protocols are implemented in compliance with study protocol and regulatory ( local and International) requirements, triaging and managing study related medical emergencies, triaging and managing clinical trial participants  medical problems,  reading and interpreting chest x rays, source document development , development of site specific addenda for multicenter international protocols, safety reporting in clinical trials, SOP development, abstract and manuscript development and proposal writing. </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Dr. Kevin Cain</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: TB branch Chief</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Dr. Cain is the chief of the TB branch for KEMRI/CDC. Dr. Cain received his MD degree from the University of Pennsylvania School of Medicine in 2001. He then completed a 3 year residency training in internal medicine, is board certified in internal medicine, and is licensed in the state of Michigan. After completing internal medicine training in 2004, Dr. Cain joined CDC in Atlanta, where he completed 2 years of applied epidemiology training as an Epidemic Intelligence Service (EIS) officer with the International Research and Programs Branch of the Division of Tuberculosis Elimination. After completing EIS in 2006, he remained at CDC in the same branch. He became team lead for TB/HIV in 2008, and he was acting chief of the branch in late 2010 and early 2011 before accepting a position with CDC Kenya as the Chief of the TB Branch for KEMRI/CDC in Kisumu.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Dr. Cain has led a variety of epidemiologic studies during his time at CDC, including studies of TB among foreign-born persons in the United States and of TB screening and diagnosis in people with HIV. Dr. Cain has over 20 publications in peer-reviewed literature, including first-author publications in the New England Journal of Medicine and the Journal of the American Medical Association. He also has authored several editorial commentaries at the invitation of scientific journals, has given multiple presentations at international conferences, and has worked closely with World Health Organization on global and regional policy. He led the development of a revised framework for TB/HIV for WHO in the Western Pacific Region. Currently, he is the US representative to the technical advisory group for TB for WHO Western Pacific Region.</p>\n<p>\n Dr. Eunice Akinyi Ouma</p>\n<p>\n Position_co-investigator</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Dr Eunice Ouma holds a bachelor’s degree in Medicine and Surgery (MBChB) from Moi University having graduated in the year 2010. Currently she works as an Assistance Research Officer with KEMRI-CGHR since July 2014. I. I have worked with the Ministry of Health as a Medical Officer prior to my current position. I currently work across various ACTG studies that are on going at our site and also in TBTC 36 AND 36A, in which I have gained a wealth of experience in both clinical and observational trials</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Lazarus Odeny</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: Senior Data Manager</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He holds the position of TB branch Senior Data Manager</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has over 10 years of data management, biostatistics and epidemiology experience. He is currently registered for a doctor of science in Epidemiology (PhD) at the Erasmus University in Rotterdam, Netherlands.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has held the following positions:</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 1.    Senior Data Analyst and Data manager – <strong>KEMRI/CDC</strong></p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 2.    Senior Data manager – International Centre for Reproductive Health (<strong>ICRH</strong>)</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 3.    Data manager – <strong>KEMRI/CDC</strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He is proficient in SAS, SPSS, EPIINFO, STATA, Microsoft office 2003 suite (Word, Excel, PowerPoint, Access), VFP, Visual CE for PDA, Microsoft visual basic, DOTNET framework, S-Plus, C + +, SQL, ISA firewall server administrator and SQL servers. All large studies conducted by the TB branch in the past several years have utilized electronic data collection and management, and this process has been designed and managed by Lazarus.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Rose Abwunza</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Quality Assurance Manager</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n She holds the position of QA manager since 2015 in the TB research branch. She is a graduate of the University of Nairobi holding a <strong>Masters in Arts (project planning and management). </strong>She has been able to participate in the following studies: 2 regulated epidemiological studies i.e. Adolescent Cohort study (an epidemiological study on TB prevalence and Incidence in adolescents), Infant Cohort study (an epidemiological study investigating the incidence of TB in Infants), and a TB vaccine study, which is ongoing and other nested studies as a training education and communication coordinator.She currently holds the position of QA/Training manager.The QA duties include management of regulatory submissions, tracking of all annual approvals, management of the essential documents<strong>, </strong>safety and deviation tracking and reporting<strong>, </strong>quality control and verification of source documents and CRFs<strong>, </strong>preparation of study files for data collection<strong>, </strong>hosting monitoring and audit visits<strong>, </strong>corrective actions follow up and archiving of study documents .</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n She has gained relevant trainings and skills during her research experience which include:  Good Clinical Practice,  ethical aspects in clinical research, and epidemiology and biostatistics; all trainings were offered by the Vienna School of Clinical Research (VSCR). </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Dr. Victor Mudhune</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: Clinical Trials Pharmacist</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He holds the position of study pharmacist in the HIV research and TB branches and is the pharmacist for the TBTC drug trial. He previously worked as a hospital pharmacist.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n His major duties as a clinical trials pharmacist include:</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 1.    Coordination of all issues related to study drug/placebo supply and preparing all doses for administration and dispensing by the nurses.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 2.    Maintaining appropriate records of the receipt and disposition of the study vaccine, placebos, benefit vaccine and inventory of all medicines.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 3.    Monitoring and documenting cold chain maintenance for all study vaccines to ensure quality of the products is not compromised.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 4.    Managing study participant randomization process and preparing the study vaccine/placebo doses for administration to study participants as per the study vaccine management manual.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 5.    Maintaining the blinding of the participant’s treatment assignment to investigators, study nurses, clinic staff and participant.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 6.    Maintaining the confidentiality of the participant, participant’s pharmacy file and the study drug/placebo accountability record.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 7.    Establishing a system to ensure that the participants sign an informed consent before dispensing the drugs and ensuring that the current IRB approved version of the protocol is adhered to in dispensing the drug/placebo.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 8.    Ensuring the security of all documents and investigational drug/placebo.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 9.    Preparing pharmacy related standard operating procedures ensuring they meet GCP, NIH and other regulatory requirements.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 10.  Following established departmental policies, procedures and objectives, continuous quality improvement objectives and safety, environmental and/or infection control standards.</p>\n<p style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n 11.  Providing overall supervision to senior TB branch staff on pharmacy related activities.</p>\n<p style=\"margin: 0px 0px 10px 1in; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has worked as a research pharmacist for the last 4.5 years as a research pharmacist and is trained in GCP, Human Subject Protection, NIH online training, and clinical trial management. He is currently training others in the same courses at the KEMRI/CDC field stations.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has been involved in site preparations for the PAVE 100 trial, a DAIDS sponsored trial and in a completed study (the Kisumu Breastfeeding Study). He also functioned as backup pharmacist in a completed vaccine study (Rotavirus Vaccine Study).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He is the clinical trial pharmacist for the HPTN 052, a DAIDS sponsored trial, and the pharmacist to:  Aeras 402 vaccine trial (TB vaccine study), the TBTC drug trial and GSK MAL055/058 Vaccine trial.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Albert Ochieng Okumu</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: Laboratory Manager</u></strong></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He holds the position of Laboratory Manager for the KEMRI/CDC, TB laboratory at the Kisian field station. His focus is on the quality and excellent performance of the KEMRI/CDC TB research laboratory. He has been able to receive into this laboratory study monitors, lab assessment visitors and auditors conducting assessments of the TB clinical trials at the site.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has received and also coordinated trainings in: Good Clinical Laboratory Practice, participation in external quality assessment programmes and developed in house Quality Control systems.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has worked previously with government health facilities in Kenya in different capacities, such as a laboratory technologist, government health facility laboratory in-charge and government laboratories district in-charge. His work with the Ministry of Health gave him experience in routine laboratory tests and procedures, laboratory diagnostics including in patients with TB and HIV of all ages.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n His initial research experience was at the Kenya Medical Research Institute, Centre for Microbiology Research, Kisumu, in an ‘Investigational New Drug’ HIV trial sponsored by the Gates foundation. This study was conducted for five years and it was implemented by Partners in Prevention (University of Washington). In his role in the study he was able to establish a functional clinical research laboratory. He also supported various sub- studies that conducted several laboratory assays for participants in microbicide studies such as: Female ViVaGel-USA, IPM (International partnerships for microbicides) of South Africa.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He has received trainings and skills in Good Clinical Laboratory Practice (GCLP) and Ethics (IAVI and Vienna School of Clinical Research), International shipping regulations (IATA, Mayo) and he has coordinated trainings in: GCLP, participation in external quality assessment programs and developed in-house Quality Control systems.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n  </p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <u>Benard Owuor</u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n <strong><u>Position: TB branch Administrative Manager</u></strong></p>\n<p align=\"left\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n He holds the position of TB branch Administrative Manager. His qualifications include: MBA (finance), BBA (Accounting), CPA and Diploma in information technology and computer sciences.</p>\n<p align=\"left\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n His work experience in accounting, auditing and management covers 10 years at KEMRI/CDC and at 2 educational institutions. He also has 6 years experience as an administrator where he has been able to demonstrate: good leadership, organisational management, team-building skills, flexibility and strong communication skills.</p>\n<p align=\"left\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n In his capacity as administrative manager in the TB research branch, KEMRI/CDC he has been able to oversee financial management, organisational management and administrative tasks for several TB branch research studies, managing budgets of millions of dollars, and handling all reporting and auditing requirements for sponsors.</p>\n
      • other_details_explanation<p>\n The trial is to be conducted in the host country of the applicant</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI Scientific Ethics Review Unit Approval date 21 Jul 2015</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration3 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_comparator2RHZE/4RH
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRICDC, KISUMU, KENYA
      • single_site_physical_addressALONG KISUMU-KAKAMEGA ROAD AT JOOTRH, CDC CLINICAL RESEARCH CENTRE
      • single_site_contact_personELISHA OKEYO
      • single_site_telephone0721410654
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_statesover 8
      • number_of_sites
      • multi_country_listUSA,Spain,South Africa,Hong Kong,Kenya,Vietnam,Peru,Uganda, various Aids Clinical Trials Groug (ACTG) sites
      • data_monitoring_committeeYes
      • total_enrolment_per_siteno minimum or maximum number
      • total_participants_worldwide2500
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameSamuel
      • investigator1_middle_nameGurrion
      • investigator1_family_nameOuma
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressP.O Box 1578, 40100 Kisumu
      • investigator1_telephone057-2022902/59/02
      • investigator1_emailSouma@kemricdc.org
      • organisations_transferred_Yes
      • number_participants50-100
      • notification
      • approval_date05-05-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-03-26 10:33:24
      • created2015-08-06 14:38:00
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id281
        • application_id413
        • given_nameElisha
        • middle_nameOchieng
        • family_nameOkeyo
        • qualificationMedical Doctor
        • professional_addressP.O Box 1578, 40100 Kisumu
        • telephone057-2022902/59/02
        • emailEokeyo@kemricdc.org
        • created2015-08-06 15:34:58
        • modified2020-03-26 10:33:24
    • SiteDetail(array)
      • 0(array)
        • id334
        • application_id413
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-08-06 15:34:58
        • modified2020-03-26 10:33:24
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id219
        • application_id413
        • sponsorCDC, NIH
        • sponsor_typeResearch Institution
        • contact_personStefan Goldberg, M.D.
        • address1600 Clifton Road, MS E-10 Atlanta, GA, USA 30333
        • telephone_number404-639-5339
        • fax_number
        • cell_number404-639-5339
        • email_addressssg3@cdc.gov
        • created2015-08-06 15:34:58
        • modified2020-03-26 10:33:24
  • 3(array)
    • Application(array)
      • id398
      • user_id77
      • trial_status_id5
      • abstract_of_study<p>\n  </p>\n<p>\n  </p>\n<p style=\"margin-left: 13.5pt\">\n  </p>\n<p>\n <strong>Project description and scope</strong></p>\n<p>\n <strong>Brief Description:</strong>     </p>\n<p>\n A5316 is a phase II, open-label, non-randomized, steady-state, parallel design trial to evaluate pharmacokinetic (PK) interactions between hormonal contraception (etonogestrel and ethinyl estradiol) delivered via a vaginal ring (NuvaRing) and efavirenz (EFV)- or atazanavir/ritonavir (ATV/r)-based regimens.  HIV-infected, non-pregnant women who are taking EFV- or ATV/r-based regimens or no antiretroviral therapy (ART) are eligible. Those subjects on ART will have intensive antiretroviral (ART) PK collected before and 3 weeks after placement of the NuvaRing.  All subjects will have weekly visits to collect blood for hormone analysis and cervicovaginal samples for immunological, microbiological and virological studies.</p>\n<p>\n  </p>\n<p>\n <strong>Objectives: </strong></p>\n<p>\n The primary objective of the study is to estimate the effect of ATV/r or EFV-based ART on the PK exposure of etonogestrel and ethinyl estradiol in HIV-infected participants using the NuvaRing.  The study will also estimate the effect of etonogestrel and ethinyl estradiol on the PK exposure of ATV, ritonavir (RTV), or EFV.  The safety of concomitant ART administered with the NuvaRing and the impact of the NuvaRing on virologic suppression, cervicovaginal immunology and microbiome will also be explored.</p>\n<p>\n  </p>\n<p>\n <strong>Requirements to Enter Study:  </strong></p>\n<p>\n <strong>     Inclusion Criteria</strong></p>\n<ul>\n <li>\n Premenopausal HIV-infected women age ³16 years</li>\n <li>\n Receiving either 1) EFV 600 mg daily with 2 or more NRTIs, 2) ATV/r 300 mg/ 100 mg daily with TDF 300 mg and 1 or more additional NRTIs, or 3) no ART; stable for 30 days prior to entry with no plans to change therapy during study</li>\n <li>\n For participants on ART: HIV-1 RNA £400 copies/mL within 60 days prior to study entry</li>\n <li>\n For participants not on ART: CD4+ cell count ≥350 cells/mm³ within 60 days prior to study entry</li>\n <li>\n Laboratory values obtained within 60 days prior to study entry:</li>\n</ul>\n<ul>\n <li>\n Hemoglobin ³8.0 g/dL</li>\n <li>\n Platelet count ³50,000/mm³</li>\n <li>\n AST and ALT £ 5 ´ ULN</li>\n <li>\n Total bilirubin £2.0 x ULN</li>\n <li>\n Creatinine ≤1.5 x ULN</li>\n <li>\n Last menstrual period £6 months or verification of FSH £40 mIU/mL, unless there is a clinical reason for amenorrhea (such as pregnancy)</li>\n <li>\n Negative pregnancy test at screening and within 24 hours of entry </li>\n <li>\n Documentation of Pap smear within 1 year prior to study entry</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Exclusion criteria: </strong></p>\n<ul>\n <li>\n Received depot medroxyprogesterone acetate (DMPA) within 4 months, or other hormonal therapies within 30 days prior to study entry</li>\n <li>\n Contraindications to receiving hormonal contraception; Receiving medications known to interfere with either ART or hormone metabolism</li>\n <li>\n Use of systemic or inhaled corticosteroids</li>\n <li>\n Less than 6 weeks postpartum at study entry</li>\n <li>\n Clinically active cervical or vaginal infection at study entry. (Gonorrhea, chlamydia, trichomonas, bacterial vaginosis testing will be performed during screening using techniques available at the local sites.)</li>\n <li>\n History of invasive cancer of the reproductive tract, malignancy or increased risk of breast cancer; abnormal vaginal bleeding, liver tumors; or serious ocular disorders </li>\n</ul>\n<p>\n  </p>\n<p style=\"margin-left: 1.5in\">\n <strong>Treatment:  </strong></p>\n<p>\n Eligible study participants will be enrolled into one of the study treatment arms:</p>\n<p>\n  </p>\n<p>\n Arm A: NuvaRing for 3 weeks with NO ART</p>\n<p>\n Arm B: NuvaRing for 3 weeks with EFV 600 mg once daily plus ≥2 NRTIs</p>\n<p>\n Arm C: NuvaRing for 3 weeks with ATV/r 300/100 mg once daily plus</p>\n<p style=\"margin-left: 2.5in\">\n  Tenofovir (TDF) 300 mg and ≥1 NRTI</p>\n<p>\n  </p>\n<p>\n NuvaRing will be provided by the study. Participants will be offered an extra NuvaRing at the day 28 visit. ART medications are not provided.           </p>\n<p>\n  </p>\n<p>\n <strong>Duration:</strong> 28 days (weekly study visits).  Vaginal aspirates will be collected at each visit. Intensive ART PK sampling will be performed over 8 hours before and after vaginal ring placement (Days 0 and 21) for the EFV and ATV/r groups.  If participants choose to use an optional vaginal ring after day 28, they will receive a follow-up phone call day 56.</p>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<p align=\"center\">\n <strong>A</strong><strong>5316</strong></p>\n<p align=\"center\">\n  </p>\n<p align=\"center\">\n  </p>\n<p align=\"center\">\n <strong>Evaluating Pharmacokinetic Interactions with Vaginal Ring Contraceptives and Antiretroviral Therapy</strong></p>\n
      • laymans_summary<p>\n This study will look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. We do not know whether the NuvaRing and ARVs interact when they are used together, so this study will look to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study will also include HIV-infected women who are not on ARVs but will use the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs.</p>\n<p>\n Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, we want to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the HIV virus, the bacterial make-up (microbiome) of the female genital track, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.</p>\n<p>\n The product under investigation in this study is the NuvaRing. The NuvaRing is a vaginal ring that has been approved by the US Food and Drug Administration as a safe and effective method of hormonal birth control. NuvaRing is a flexible ring that is inserted into the vagina once a month and releases a small dose of hormones that prevents pregnancy.</p>\n
      • short_titleA5316
      • protocol_noECCT/15/06/04
      • version_noFinal 1.0
      • date_of_protocol02-08-2013
      • study_drugReceiving either 1) EFV 600 mg daily with 2 or more NRTIs, 2) ATV/r 300 mg/ 100 mg daily with TDF 300 mg and 1 or more additional NRTIs, or 3) no ART; stable for 30 days prior to entry with no plans to change therapy during study
      • disease_conditionHIV positive women
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameetorogestrel and ethinylestradiol
      • product_type_medical_device_nameNuvaring
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantElizabeth Ayuo
      • declaration_date114-05-2015
      • declaration_principal_investigatorDr. Esther Mumbi Makanga - National PI
      • declaration_date214-05-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n  </p>\n<ul>\n <li>\n Premenopausal HIV-infected women age ³16 years</li>\n <li>\n Receiving either 1) EFV 600 mg daily with 2 or more NRTIs, 2) ATV/r 300 mg/ 100 mg daily with TDF 300 mg and 1 or more additional NRTIs, or 3) no ART; stable for 30 days prior to entry with no plans to change therapy during study</li>\n <li>\n For participants on ART: HIV-1 RNA £400 copies/mL within 60 days prior to study entry</li>\n <li>\n For participants not on ART: CD4+ cell count ≥350 cells/mm³ within 60 days prior to study entry</li>\n <li>\n Laboratory values obtained within 60 days prior to study entry:</li>\n</ul>\n<ul>\n <li>\n Hemoglobin ³8.0 g/dL</li>\n <li>\n Platelet count ³50,000/mm³</li>\n <li>\n AST and ALT £ 5 ´ ULN</li>\n <li>\n Total bilirubin £2.0 x ULN</li>\n <li>\n Creatinine ≤1.5 x ULN</li>\n <li>\n Last menstrual period £6 months or verification of FSH £40 mIU/mL, unless there is a clinical reason for amenorrhea (such as pregnancy)</li>\n <li>\n Negative pregnancy test at screening and within 24 hours of entry </li>\n <li>\n Documentation of Pap smear within 1 year prior to study entry</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n  </p>\n<ul>\n <li>\n Received depot medroxyprogesterone acetate (DMPA) within 4 months, or other hormonal therapies within 30 days prior to study entry</li>\n <li>\n Contraindications to receiving hormonal contraception; Receiving medications known to interfere with either ART or hormone metabolism</li>\n <li>\n Use of systemic or inhaled corticosteroids</li>\n <li>\n Less than 6 weeks postpartum at study entry</li>\n <li>\n Clinically active cervical or vaginal infection at study entry. (Gonorrhea, chlamydia, trichomonas, bacterial vaginosis testing will be performed during screening using techniques available at the local sites.)</li>\n <li>\n History of invasive cancer of the reproductive tract, malignancy or increased risk of breast cancer; abnormal vaginal bleeding, liver tumors; or serious ocular disorders </li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n To estimate the effect of ongoing ART containing either once daily ATV/r or EFV, in addition to two or more nucleosides/nucleotides, on the pharmacokinetic (PK) exposure of etonogestrel and ethinyl estradiol in HIV-infected participants at day 21 after placement of the etonogestrel/ethinyl estradiol vaginal ring (NuvaRing</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n Dr. Mumbi Makanga</div>\n<div>\n MBChB, MPH</div>\n<div>\n Principal Investigator and Study Medical Officer,</div>\n<div>\n HIV Research Branch,</div>\n<div>\n KEMRI/CDC, (Kisumu)</div>\n<div>\n Will oversee daily study operations and implementation. Will supervise Kisumu-based study staff. Substantial input into site-specific study design, protocol development and assessment tools.</div>\n<div>\n Will provide patient management oversight, including clinical guidance on patient management, and medical care. Will guide study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n<div>\n  </div>\n<div>\n <div>\n Clement Zeh</div>\n <div>\n PhD, MPH</div>\n <div>\n Co-Principal Investigator,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n CDC Kenya (Kisumu)</div>\n <div>\n Will provide input for data analysis and will write report. Will be a member of the protocol team with substantial input into site-specific study design, protocol development and assessment tools. Will assist with study implementation, data analysis and report writing.</div>\n <div>\n  </div>\n <div>\n <div>\n Dr. Victor Mudhune</div>\n <div>\n BPharm, MBA, MPH(c)</div>\n <div>\n Co-Principal Investigator and Study Pharmacist,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC, (Kisumu)</div>\n <div>\n Will provide input for data analysis and will be a member of the protocol team with substantial input into site-specific study design, protocol development and assessment tools. Will oversee all pharmaceutical aspects of the study and maintain oversight of study drugs. Will provide input for study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n  </div>\n <div>\n <div>\n Taraz Samandari</div>\n <div>\n MD, PhD.</div>\n <div>\n Co-Investigator</div>\n <div>\n CDC ,Atlanta</div>\n <div>\n Will provide support for study from CDC Atlanta, including liaison with ACTG. Will provide substantial input into protocol development. Will guide study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Robert T. Chen</div>\n <div>\n MD, MA</div>\n <div>\n Co-Investigator</div>\n <div>\n CDC, Atlanta</div>\n <div>\n Will provide support for study from CDC Atlanta, including liaison with ACTG. Will provide substantial input into site-specific study design, protocol development and assessment tools. Will guide study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Allan Taylor</div>\n <div>\n MD, MPH</div>\n <div>\n Co-investigator</div>\n <div>\n CDC, Atlanta</div>\n <div>\n Will provide substantial input into site-specific study design, protocol development and assessment tools. Will guide study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n <div>\n John Okanda</div>\n <div>\n BSc, MPH(c)</div>\n <div>\n Quality Assurance Officer</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC, (Kisumu)</div>\n <div>\n Will make sure all field components of the study, are done according to the protocol, study team and investigators, will provide input for study implementation, data analysis and report writing.</div>\n <div>\n  </div>\n <div>\n <div>\n Collin Odhiambo</div>\n <div>\n MSc, PhD(c)</div>\n <div>\n Laboratory Lead,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC, (Kisumu)</div>\n <div>\n Will oversee all laboratory aspects of the study and maintain oversight of laboratory procedures. Will provide input for study implementation, data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Richard Ndivo</div>\n <div>\n MSc</div>\n <div>\n Lead Data Manager,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC (Kisumu)</div>\n <div>\n Will oversee all data aspects of this study and will be involved in all site-specific data analysis and report writing. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Elizabeth Ayuo</div>\n <div>\n BA</div>\n <div>\n Lead Regulatory officer</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC (Kisumu)</div>\n <div>\n Will provide guidance and oversight over all of the regulatory aspects of this study, including quality assurance and quality control, and ensure that all staff are GCP trained and compliant. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n Ken Ondenge</div>\n <div>\n BA</div>\n <div>\n Lead Behavioral Scientist</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC (Kisumu)</div>\n <div>\n Will provide guidance and oversight over all of the qualitative aspects of this study and will be involved in site-specific study implementation with regard to liaising with all stakeholders/community. Will be a member of the protocol team.</div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n  </div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n  </div>\n <div>\n <div>\n Carren Amondi</div>\n <div>\n BBA</div>\n <div>\n Administrative Officer,</div>\n <div>\n HIV Research Branch,</div>\n <div>\n KEMRI/CDC Kenya (Kisumu)</div>\n <div>\n Will provide oversight of all administrative aspects of this study, including budget</div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n</div>\n<p style=\"margin: 0px 0px 10px\">\n  </p>\n<p style=\"margin: 0px 0px 10px\">\n  </p>\n
      • other_details_explanation<p>\n The trial is being done in the U.S and other places as indicated;</p>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11448\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Alabama CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10018\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Barranco CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10051\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Bhumibol Adulyadej Hospital</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10059\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> CAPRISA Umlazi Clinical Research Site (UKZN)</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10184\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Chapel Hill CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10278\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Columbia Physicians & Surgeons (P&S) CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11530\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> David Geffen School of Medicine at UCLA NICHD CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10013\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Gaborone CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10000\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Instituto de Pesquisa Clinica Evandro Chagas CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10065\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Jacobi Medical Center Bronx</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11442\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11455\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> New Jersey Medical School Clinical Research Center CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10004\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Parirenyatwa CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10227\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Puerto Rico AIDS Clinical Trials Unit CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11328\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Rush University Cook County Hospital Chicago NICHD CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10098\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> San Juan City Hospital</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10019\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> San Miguel CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10046\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Shandukani Research CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10085\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> South Florida CDTC Ft Lauderdale NICHD CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/11441\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> Thai Red Cross AIDS Research Center Treatment (TRC-ARC Treatment) CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10281\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> The Miriam Hospital (TMH) CRS</a></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n <a href=\"https://member.actgnetwork.org/s/10137\"><img src=\"file:///C:\\Users\\eayuo\\AppData\\Local\\Temp\\msohtmlclip1\\01\\clip_image001.png\" /> The University of Miami AIDS Clinical Research Unit (ACRU) CRS</a></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute Scientific Ethical Review Unit (SERU)</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration28 days for every participant from day of entry
      • design_controlled_randomisedNo
      • 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_comparatorArm A (n=25): NuvaRing fo
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI- CDC
      • single_site_physical_addressPO BOX 1578
      • single_site_contact_personDr Mumbi Makanga
      • single_site_telephone+254714063448
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site10
      • total_participants_worldwide75
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. Esther Mumbi
      • investigator1_middle_name
      • investigator1_family_nameMakanga
      • investigator1_qualificationMBchB, MPH
      • investigator1_professional_addressBOX 1578, KISUMU, 40100
      • investigator1_telephone+254714063448
      • investigator1_emailmmakanga@kemricdc.org
      • organisations_transferred_No
      • number_participants40
      • notification<p>\n None</p>\n
      • approval_date17-07-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-06-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This study was done to look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. The investigators did not know whether the NuvaRing and ARVs interact when they are used together, so this study looked to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study also included HIV-infected women who were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs.</p>\n<p>\n Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, the investigators wanted to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of the female genital tract, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.</p>\n
      • implication_results<p>\n We found that efavirenz–based ART significantly decreased the systemic exposure to both etonogestrel and ethinyl estradiol released from a IVR (79% and 59% lower, respectively) compared to women with HIV not receiving ART. Our findings raise concern for the effectiveness of the IVR contraceptive in women receiving efavirenz–based ART, and studies evaluating ovulation rates in the context of this DDI are necessary. In contrast, atazanavir–ritonavir containing ART resulted in variable influence on contraceptive hormone exposure compared to women not receiving ART (71% higher etonogestrel, 38% lower ethinyl estradiol). Hence, atazanavir/ritonavir–based ART is unlikely to influence the IVR contraceptive effectiveness, as progestin exposure was higher than controls. Despite these changes, no excess AEs were reported in the atazanavir/ritonavir group compared to controls. The influence of ART on etonogestrel is likely mediated via CYP3A4, the enzyme primarily responsible for etonogestrel metabolism, due to CYP3A4 induction by efavirenz and inhibition by atazanavir/ritonavir. The effect of ART on ethinyl estradiol is also likely related to induction of multiple pathways of ethinyl estradiol metabolism by both efavirenz and atazanavir/ritonavir. Although NRTIs were administered in both ART arms, studies have not observed significant DDIs between NRTIs and hormonal contraceptives.</p>\n
      • quantity_imported54
      • quantity_dispensed15
      • quantity_destroyed39
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2021-08-24 08:28:52
      • created2015-05-13 11:32:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id270
        • application_id398
        • given_nameDr. Esther Mumbi Makanga
        • middle_name
        • family_nameMakanga
        • qualificationMBchB, MPH
        • professional_addressBOX 1578, KISUMU, 40100
        • telephone+254714063448
        • emailmmakanga@kemricdc.org
        • created2015-05-13 12:04:50
        • modified2015-06-22 08:51:27
      • 1(array)
        • id271
        • application_id398
        • given_nameDr. Victor Akelo
        • middle_name
        • family_nameAkelo
        • qualificationMBchB, MPH
        • professional_addressBOX 1578, KISUMU, 40100
        • telephone+2540714063445
        • emailvakelo@kemricdc.org
        • created2015-05-13 12:04:58
        • modified2015-06-22 08:51:27
      • 2(array)
        • id272
        • application_id398
        • given_nameDr.Victor O. Mudhune
        • middle_name
        • family_nameMudhune
        • qualificationBpharm
        • professional_addressBOX 1578, KISUMU, 40100
        • telephone+254722687430
        • emailvotieno2@kemricdc.org
        • created2015-05-13 12:31:59
        • modified2015-06-22 08:51:27
      • 3(array)
        • id273
        • application_id398
        • given_nameDr. Kevin P. Cain
        • middle_name
        • family_nameCain
        • qualificationMD
        • professional_addressBOX 1578, KISUMU, 40100
        • telephone+254710602786
        • emailbvz1@cdc.gov
        • created2015-05-13 12:31:59
        • modified2015-06-22 08:51:27
    • SiteDetail(array)
      • 0(array)
        • id326
        • application_id398
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-05-13 12:04:50
        • modified2015-06-22 08:51:27
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id210
        • application_id398
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_type(null)
        • contact_person
        • address645 N. Michigan Avenue, Suite 900
        • telephone_number312-926-3693
        • fax_number
        • cell_number312-926-3693
        • email_addresssusan-cohn@northwestern.edu
        • created2015-05-13 12:04:50
        • modified2015-06-22 08:51:27
      • 1(array)
        • id211
        • application_id398
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_type(null)
        • contact_personSusan E. Cohn, MD, MPH
        • address645 N. Michigan Avenue, Suite 900
        • telephone_number312-926-3693
        • fax_number
        • cell_number312-926-3693
        • email_addresssusan-cohn@northwestern.edu
        • created2015-05-13 12:04:58
        • modified2015-06-22 08:51:27
  • 4(array)
    • Application(array)
      • id354
      • user_id229
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background</strong>: WHO guidelines recommend second-line antiretroviral therapy for adults consisting of two NRTIs + a ritonavir-boosted protease inhibitor (PI); atazanavir plus ritonavir (ATV+RTV) or lopinavir (LPV)/RTV are the preferred boosted PI options. Several studies have been conducted or are currently underway to investigate novel treatment strategies (i.e. NRTI-sparing regimens) in patients requiring second-line ART. <span style=\"line-height: 115%; font-family: Arial, sans-serif; font-size: 9pt;\">There are currently no studies ongoing to explore the potential option of PI-sparing second-line ART. </span>Further data is needed on best treatment options for HIV-1 infected people who have virological failure with this first-line regimen. This study compares a second-line regimen of DTG (dolutegravir) plus two NRTIs with a WHO-recommended regimen of LPV/RTV with two NRTIs.</p>\n<p>\n <strong>Objectives</strong>: The main aim of this study is to demonstrate non-inferior antiviral activity at 48 weeks of a DTG containing regimen (DTG 50 mg once daily + two NRTIs) compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV + two NRTIs, in HIV-1 infected patients failing first line therapy.</p>\n<p>\n <strong>Methods</strong>: This study is a Phase IIIb, randomised, open-label, active-controlled, multicenter, parallel group, non-inferiority study. Approximately 612 adult patients with confirmed virologic failure (HIV-1 RNA more than or equal to 400 c/mL on two occasions) on their first antiretroviral regimen consisting of one NNRTI + two NRTIs will be recruited in 13 countries. In Kenya, there will be two sites: the Kenya Medical Research Institute (KEMRI) Research Care and Training Programme, Family AIDS Care and Education Programme (FACES) based at the Centre for Microbiology Research at Lumumba health centre in Kisumu County, and the KEMRI-FACES at the Centre for Respiratory Diseases Research (CRDR), Nairobi. Participants will be randomised 1:1 to receive DTG 50 mg once daily or LPV/RTV (800/200 mg once daily or 400/100 mg twice daily), each added to an investigator selected background regimen consisting of two NRTIs with at least one fully active NRTI.</p>\n<p>\n <strong>Analysis</strong>: The primary analysis at Week 48 will take place after the last subject completes 52 weeks on therapy (Day 1 to Week 48 plus a 4-week treatment extension). An interim analysis and data cut will be conducted after the last subject completes 24 weeks on therapy, with the intent to provide an earlier assessment of efficacy to inform the Sponsor and clinicians.</p>\n
      • study_title<p>\n A Phase 3b, randomised, open-label study of the antiviral activity and safety of dolutegravir compared to lopinavir/ritonavir both administered with dual nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected adult subjects with treatment failure on first line therapy</p>\n
      • laymans_summary(null)
      • short_titleDolutegrAvir With NRTIs as second-line treatment (DAWNING)
      • protocol_noECCT/15/06/03
      • version_no01
      • date_of_protocol30-04-2014
      • study_drugDolutegravir 50 mg tablets; Lopinavir/ritonavir tablets
      • disease_conditionHIV-1 AIDS
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDolutegravir
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgodfrey.m.nyakaya@gsk.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantGodfrey Nyakaya
      • declaration_date116-06-2015
      • declaration_principal_investigatorDr. William Mwiti, Medical Director- Kenya, GlaxoSmithKline, Likoni Rd, Nairobi
      • declaration_date216-06-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. Signed and dated written Informed Consent obtained prior to screening.</p>\n<p>\n 2. HIV-1 infected men or women ≥18 years.</p>\n<p>\n • Women of childbearing potential must use adequate contraception (see Protocol Section 4.2).</p>\n<p>\n 3. On a first-line treatment regimen consisting of an NNRTI plus two NRTIs for at least 6 months and is currently experiencing virologic failure:</p>\n<p>\n • HIV-1 RNA ≥400 c/mL at Screening + at least one previous HIV-1 RNA result of ≥400 c/mL within the 3 months prior to Screening.</p>\n<p>\n • If HIV-1 RNA within 3 months prior to Screening not available, a second HIV-1 RNA must be performed during the Screening period and have results of ≥400 c/mL.</p>\n<p>\n 4. At least one fully active agent within the dual-NRTI background regimen for second line treatment. Fully active: no evidence of full or partial resistance as per Screening genotypic resistance report.</p>\n<p>\n 5. Is PI-naïve and INI-naïve, defined as no prior or current exposure to any PI or INI.</p>\n
      • principal_exclusion_criteria<p>\n 1. Women who are breastfeeding. </p>\n<p>\n 2. Active CDC Category C disease, except:</p>\n<p>\n • cutaneous Kaposi’s sarcoma not requiring systemic therapy</p>\n<p>\n • historic or current CD4+ cell levels <200 cells/mm3. </p>\n<p>\n 3. Severe hepatic impairment (Child-Pugh Class C). </p>\n<p>\n 4. Unstable liver disease (Ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (except Gilbert's syndrome, asymptomatic gallstones).</p>\n<p>\n 5. Anticipated need for HCV therapy (during the Randomised Phase). </p>\n<p>\n 6. History or presence of allergy or intolerance to study drugs or their components or drugs of their class. </p>\n<p>\n 7. Ongoing malignancy (other than specified localized malignancies, e.g. Kaposi’s sarcoma, cervical intraepithelial neoplasia). </p>\n<p>\n 8. In the investigator’s opinion, significant suicidality risk.</p>\n<div>\n 9. HIV immunotherapeutic vaccine within 90 days of Screening</div>\n<div>\n  </div>\n<div>\n 10. Radiation, cytotoxic chemotherapy or systemically administered immunomodulators within 28 days of Screening</div>\n<div>\n  </div>\n<div>\n 11. Treatment with any agent, other than licensed ART as allowed per inclusion criteria, with documented activity against HIV-1 in vitro/vivo within 28 days of first dose of IP. </div>\n<div>\n • Exception: entecavir, in appropriate clinical situations, for treatment of hepatitis B (e.g. prior intolerance to TDF, viral resistance to 3TC /FTC) after discussion and agreement between investigator and medical monitor.</div>\n<div>\n  </div>\n<div>\n 12. Exposure to any experimental drug or vaccine within 28 days or 5 half-lives  of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to first dose of IP</div>\n<div>\n  </div>\n<div>\n <div>\n 13. Primary viral resistance to PIs or INIs based on the presence of any major resistance-associated mutation.</div>\n <div>\n  </div>\n <div>\n 14. Subject’s virus does not yield results using genotype at Screening.</div>\n <div>\n  </div>\n <div>\n 15. Any verified Grade 4 laboratory abnormality with the exception of Grade 4 triglyceride abnormalities.</div>\n <div>\n  </div>\n <div>\n 16. Any acute lab abnormality which would exclude subject’s participation in a study of an investigational drug</div>\n <div>\n  </div>\n <div>\n 17. ALT ≥5xULN or ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin).</div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<p>\n The proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure) for the intent-to-treat exposed (ITT-E) population.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Please refer to appendix I: 'Capacity of Sites DTG 200304' under 'Notifications' section for a description of sites' capacity.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The trial will be conducted in 13 countries globally. This study is aimed at low-income and middle-income countries where the WHO HIV-treatment guidelines are followed. Kenya follows the WHO treatment guidelines. Kenya has a HIV-1 burden with relatively high rates of resistance to WHO recommended first line regimen. We completed country feasibility that confirmed that Kenya has the suitable patient population.The data collected from Kenya is aimed at supporting the registration of a new INI regimen in the region.</p>\n
      • other_details_regulatory_notapproved<p>\n The table below provides the name of other regulatory authorities to which applications to conduct this trial have been submitted, but approval not yet granted.</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"1\" style=\"width:500px;\" width=\"500\">\n <tbody>\n <tr>\n <td>\n <p>\n <strong>Name of competent Authority</strong></p>\n </td>\n <td>\n <p>\n <strong>Submission Date</strong></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Pharmacy and Poisons Board, Kenya</p>\n </td>\n <td>\n <p>\n   June, 2015</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n The table below summaries the number of sites planned in which the Regulatory Authorities have approved this trial.</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"1\" height=\"556\" width=\"802\">\n <tbody>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Name of Competent Authority</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n Date of approval</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n Number of planned centres</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n ANMAT, Argentina</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 11^th November, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n ISP, Chile</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 22^nd October, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Roszdrav Nadzor, Russia</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 11^th August, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Medicines Control Council, South Africa</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 23^rd September, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n General Directorate of Pharmaceuticals, Devices and Drugs, Peru</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 28^th November, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 6</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n COFEPRIS, Mexico</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 8th January 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n INVIMA (National Institute for Drug and Food Surveillance), Colombia</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 15th January 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n China</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 13^th February 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Romania</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 5^th February 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Thailand</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 4^th February 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Ukraine</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 22^nd May 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Brazilian Health Surveillance Agency (Anvisa), Brazil</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 8^th May 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 4</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration52 weeks.
      • 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_comparatorLopinavir/ritonavir (Kale
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyDolutegravir tablets and Kaletra (LPV/r) tablets are administered with 2 background investigator-selected locally approved NRTIs, with at least one fully active NRTI within the background regimen based on Screening genotype resistance results.
      • 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_states13
      • number_of_sites2
      • multi_country_listArgentina, Brazil, Chile, China, Colombia, Kenya, Mexico, Peru, Romania, Russia, South Africa, Thailand, Ukraine
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKEMRI CRDR Nairobi: 20 participants,\nKEMRI FACES St. Lumumba Health center Kisumu: 10 participants
      • total_participants_worldwide612
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. William
      • investigator1_middle_name
      • investigator1_family_nameMwiti
      • investigator1_qualificationMB.ChB,
      • investigator1_professional_addressGlaxoSmithKline, Likoni Rd, P. O. Box 78392 - 00507, Nairobi, Kenya
      • investigator1_telephone+254 20 69 33 329, +254 700 470466, +254 721 291882
      • investigator1_emailwilliam.m.mwiti@gsk.com
      • organisations_transferred_Yes
      • number_participants30
      • notification<p>\n For any information, queries or enquiries please contact:</p>\n<p>\n Godfrey Nyakaya, GSK Kenya, Clinical Research Associate, Email: <strong><a href=\"mailto:jacqueline.r.wanja@gsk.com\">godfrey.m.nyakaya@gsk.com</a> </strong>, Mobile: +254 734 227505, Address: GlaxoSmithKline Kenya, P. O. Box 78392 - 00507, Likoni Rd, Nairobi</p>\n<p>\n Or:</p>\n<p>\n Dr. William Mwiti, GSK Kenya, Medical Director - Kenya, Email: <strong><a href=\"mailto:william.m.mwiti@gsk.com\">william.m.mwiti@gsk.com</a> </strong>, Mobile: +254 700 470466, +254 721 291882, Office: +254 20 69 33 329, Address: GlaxoSmithKline Kenya, P. O. Box 78392 - 00507, Likoni Rd, Nairobi</p>\n
      • approval_date29-07-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-06-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The Site enrolled 29 Study participants: 15 in DTG Arm and 14 on LPV/RTV.</p>\n<ul>\n <li>\n 5 participants were withdrawn before they completed the study due to various reasons:</li>\n <li>\n 3 due to Viral rebound</li>\n <li>\n 1 died due to meningoencephalitis</li>\n <li>\n 1 due to Severe Anaemia secondary to AZT</li>\n <li>\n The other 24  participants completed the study period but 14 on DTG Arm continued with the study until June when they were transferred back to NASCOP when the drug was available.</li>\n</ul>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2019-07-19 10:14:25
      • created2014-11-27 16:14:22
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id249
        • application_id354
        • given_nameDr. Evans
        • middle_nameInyangala
        • family_nameAmukoye
        • qualificationMB.ChB, M.Med (Paed)
        • professional_addressCenter for Respiratory Diseases Research, CRDR, KEMRI, P.O. Box 47855 – 00100, Nairobi
        • telephone+254 722634383
        • emailamukoye@gmail.com
        • created2014-11-27 16:38:11
        • modified2015-06-16 14:18:21
      • 1(array)
        • id251
        • application_id354
        • given_nameDr. Maricianah
        • middle_nameAtieno
        • family_nameOnono
        • qualificationMB.ChB, Certificate (Research Methods), M.Sc (Clinical Research), Fogarty Fellowship (Global Health)
        • professional_addressKEMRI-Research Care and Training Program (RCTP), Family AIDS Care and Education Services (FACES), Lumumba health centre, Off Agoi Road, PO BOX 614 - 40100, Kisumu
        • telephone+254 732 39 09 92
        • emailmonono@kemri-ucsf.org
        • created2014-11-27 16:38:11
        • modified2015-06-16 14:18:21
    • SiteDetail(array)
      • 0(array)
        • id300
        • application_id354
        • county_id47
        • site_nameCenter for Respiratory Diseases Research, CRDR, KEMRI, Nairobi
        • physical_addressP.O. Box 47855 – 00100, Nairobi
        • contact_detailsamukoye@gmail.com, Mobile: +254 722 634383
        • contact_personDr. Evans Inyangala Amukoye
        • site_capacity(null)
        • misc(null)
        • created2014-11-27 16:38:11
        • modified2015-06-16 14:18:21
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id302
        • application_id354
        • county_id42
        • site_nameKEMRI-Research Care and Training Program (RCTP), Family AIDS Care and Education Services (FACES), Lumumba health centre
        • physical_addressOff Agoi Road, PO BOX 614 - 40100, Kisumu
        • contact_detailsmonono@kemri-ucsf.org, Mobile: +254 732 390992
        • contact_personDr. Maricianah Atieno Onono
        • site_capacity(null)
        • misc(null)
        • created2014-11-28 16:47:52
        • modified2015-06-16 14:18:21
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id189
        • application_id354
        • sponsorGlaxoSmithKline Kenya Ltd, Nairobi
        • sponsor_type(null)
        • contact_personGodfrey Nyakaya/ Dr. William Mwiti
        • addressGSK, Likoni Road, P. O. Box 78392 - 00507, Nairobi
        • telephone_number+254 20 69 33 200/ 20 69 33 329
        • fax_number
        • cell_number+254 734 227505, +254 700 470466
        • email_addressgodfrey.m.nyakaya@gsk.com
        • created2014-11-27 16:38:11
        • modified2015-06-16 14:18:21
      • 1(array)
        • id198
        • application_id354
        • sponsorViiV Healthcare
        • sponsor_type(null)
        • contact_personNassrin Payvandi
        • address980 Great West Road, Brentford, Middlesex, TW8 9GS, UK
        • telephone_number+44 (0)20 8380 6218
        • fax_number
        • cell_number+44 (0) 7717 800810
        • email_addressnassrin.x.payvandi@viivhealthcare.com
        • created2015-02-02 09:43:39
        • modified2015-06-16 14:18:21
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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