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• trial_statuses(array)
  • 1Recruiting
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  • 8Writing-up
  • 9Application withdrawn
• applications(array)
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    • Application(array)
      • id75
      • user_id63
      • trial_status_id8
      • abstract_of_study<p>\n  </p>\n<p>\n The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of  experimental intensive phase (first 8 weeks of treatment) tuberculosis treatment regimens in which rifapentine is substituted for rifampin.  </p>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<p>\n Evaluation of a rifapentine-containing regimen for intensive phase treatment of pulmonary tuberculosis</p>\n
      • laymans_summary(null)
      • short_titleRifapentine During Intensive Phase TB Treatment
      • protocol_noECCT/11/08/05
      • version_no2.1
      • date_of_protocol15-02-2011
      • study_drugRifapentine
      • disease_conditionTuberculosis
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameRifapentine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressLMatata@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_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_applicantDr Lena Matata
      • declaration_date130-07-2013
      • declaration_principal_investigatorNot Applicable
      • declaration_date230-07-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n  </p>\n<p>\n Inclusion Criteria</p>\n<p style=\"margin-left:40.5pt;\">\n <u>Subjects must meet all inclusion criteria in order to participate in this study.</u></p>\n<p style=\"margin-left:1.1in;\">\n 1.      Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated or induced sputum. </p>\n<p style=\"margin-left:1.1in;\">\n 2.      Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 3 months prior to enrollment.</p>\n<p style=\"margin-left:1.1in;\">\n 3.      5 (five) or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding initiation of study drugs.</p>\n<p style=\"margin-left:1.1in;\">\n 4.      7 (seven) or fewer days of fluoroquinolone therapy in the 30 days preceding initiation of study drugs.</p>\n<p style=\"margin-left:1.1in;\">\n 5.      Age <u>></u> 18 years</p>\n<p style=\"margin-left:1.1in;\">\n 6.      Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix B)</p>\n<p style=\"margin-left:1.1in;\">\n 7.      Signed informed consent</p>\n<p style=\"margin-left:1.1in;\">\n 8.      Women of child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy.</p>\n<p style=\"margin-left:1.1in;\">\n 9.      Laboratory parameters done £ 14 days prior to, enrollment:</p>\n<div style=\"margin-left:1.1in;\">\n <p>\n ·         Serum or plasma alanine aminotransferase (ALT) activity ≤ 3 times the upper limit of normal</p>\n <p>\n ·         Serum or plasma total bilirubin level ≤ 2.5 times the upper limit of normal</p>\n <p>\n ·         Serum or plasma creatinine level ≤ 2 times the upper limit of normal</p>\n <p>\n ·         Complete blood count with hemoglobin level of at least 7.0 g/dL</p>\n <p>\n ·         Complete blood count with platelet count of at least 100,000/mm³</p>\n</div>\n<p style=\"margin-left:1.35in;\">\n ·         Negative pregnancy test (women of childbearing potential)</p>\n
      • principal_exclusion_criteria<p>\n  </p>\n<p>\n Exclusion Criteria</p>\n<p style=\"margin-left:40.5pt;\">\n <u>All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:</u></p>\n<p style=\"margin-left:1.1in;\">\n 1.      Pregnant or breast-feeding</p>\n<p style=\"margin-left:1.1in;\">\n 2.      Known intolerance or allergy to any of the study drugs</p>\n<p style=\"margin-left:1.1in;\">\n 3.      Concomitant disorders or conditions for which isoniazid (INH), rifamycins, pyrazinamide (PZA), or ethambutol (EMB) are contraindicated.  These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.</p>\n<p style=\"margin-left:1.1in;\">\n 4.      Current or planned therapy, during the intensive phase of TB therapy, with combination antiretroviral therapy for HIV, or with cyclosporine or tacrolimus.  Cyclosporine and tacrolimus have unacceptable interactions with rifamycins. </p>\n<p style=\"margin-left:1.1in;\">\n 5.      Pulmonary silicosis</p>\n<p style=\"margin-left:1.1in;\">\n 6.      Central nervous system TB</p>\n<p style=\"margin-left:1.1in;\">\n 7.      Weight < 40 kg or > 85 kg</p>\n
      • primary_end_points<p>\n  </p>\n<p style=\"margin-left:40.5pt;\">\n <strong>Sputum culture conversion</strong> –The <u>primary efficacy endpoint</u> is the culture result at the end of intensive phase therapy.  <u>Secondary efficacy endpoints</u> include time to the first negative culture result and time to “culture conversion,” defined as the first of two consecutive monthly culture-negative sputum specimens that are not followed by a culture-positive specimen.  The end of the intensive phase of therapy will be defined by completion of the required number of directly-observed doses (as defined in Section 5.1), rather than by a specific number of weeks of therapy.  In order to assure that each subject will be evaluable for the primary endpoint, two sputum specimens will be obtained at the end of the intensive phase of therapy.  Sputum culture conversion will be based on the results of both sputum specimens performed at the end of the intensive phase of therapy. <strong> All evaluable mycobacterial cultures from both sputum specimens obtained at the end of intensive phase should be negative for <em>M. tuberculosis</em>, and no subsequently obtained sputum should have growth of <em>M. tuberculosis</em>, in order to conclude that sputum culture conversion was achieved.</strong>  Sputum cultures that are overgrown by bacteria and/or yeast will be considered unevaluable.  Subjects who are unable to produce a specimen for sputum culture despite an attempt with sputum induction will be considered to have had a negative culture on that date. </p>\n<p style=\"margin-left:40.5pt;\">\n  </p>\n<p style=\"margin-left:40.5pt;\">\n <strong>Safety and tolerability endpoints</strong> – the primary endpoint for the analysis of safety and tolerability will be the proportion of patients who, after taking one or more doses of study drugs, permanently discontinue the assigned study regimen for any reason other than being found to be ineligible for continuing in the study (because of drug-resistance, or lack of growth of <em>M. tuberculosis</em> from the initial sputum culture. Other aspects of safety and tolerability that will be assessed as secondary endpoints include mortality, the occurrence of Grade 3 and 4 toxicities and the rate and types of toxicity thought possibly, probably, or definitely related to study drug by the investigator. </p>\n<p>\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n  </p>\n<p>\n STAFF IN THIS STUDY: 2 MEDICAL DOCTORS, 1 PHARMACIST, 1 FULL-TIME NURSE, 1 PART TIME NURSE, 1 CO-ORDINATOR, 1 COMMUNITY MOBILISATION OFFICER, 1 QA MANAGER, OFFICERS, 1 QC OFFICER, 1 DATA MANAGER, 1 DATA OFFICER, 1 DATA SPECIALIST.</p>\n<p>\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>\n  </p>\n<p>\n  </p>\n<p>\n <u><strong>Profiles of key staff in TB Branch at KEMRI/CDC:</strong></u></p>\n<p>\n  </p>\n<p>\n <u>Dr. Kevin Cain</u></p>\n<p>\n <strong><u>Position: TB branch Chief</u></strong></p>\n<p>\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>\n  </p>\n<p>\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  </p>\n<p>\n <u>Dr. Videlis Nduba</u></p>\n<p>\n <strong>Principal Investigator, Aeras 402 (NOCHAK) TB vaccine Trial, Adolescent and Infant TB cohort studies</strong></p>\n<p>\n  </p>\n<p>\n Dr. Nduba is a principal investigator in the TB Research Branch, KEMRI/CDC where he leads the TB vaccine research section.  He completed his medical degree at the University of Nairobi and proceeded to do a masters degree in public health at the university of Washington, Seattle, USA. He is currently enrolled as a PhD student at the University of Amsterdam, The Netherlands.</p>\n<p>\n  </p>\n<p>\n Dr. Nduba previously worked in various research programs at KEMRI including acute bronchitis, pneumonia and HIV where he took various roles as a study doctor and a study coordinator.  For the last four years Dr. Nduba has been involved in development of TB research capacity at KEMRI/CDC. This included conducting TB incidence cohort studies in infants and adolescents, part of which included improving TB research infrastructure such as TB laboratory upgrades funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and the Aeras Global TB Vaccine Foundation.  Dr. Nduba has attended numerous courses as part of the capacity development process including, Good Clinical Practice (GCP), Ethical conduct of clinical trials, Project management and is a certified B grade reader for Chest X-rays using the Chest Radiograph and Recording system for interpreting chest x-rays in TB prevalence surveys.</p>\n<p>\n He is currently the principal investigator for a multisite Phase IIB TB vaccine trial sponsored by the Aeras Global TB vaccine foundation. He has made numerous scientific presentations in international conferences and is a co author on several articles published in peer reviewed journals.</p>\n<p>\n  </p>\n<p>\n <u>Dr. Lena Matata</u></p>\n<p>\n <strong><u>Position: Principal Investigator, Tuberculosis Trials Consortium (TBTC) study</u></strong></p>\n<p>\n  </p>\n<p>\n She holds the position of Principal Investigator for the Tuberculosis Trials Consortium (TBTC) drug trial. This is a multi-center clinical trial sponsored by CDC, Atlanta. It will evaluate a new TB treatment regimen that contains an experimental TB drug Rifapentine.</p>\n<p>\n  </p>\n<p>\n She has worked previously in 3 government health facilities in Kenya in different capacities: medical doctor, research doctor and project manager. This includes working as a medical doctor, in the care of patients with HIV/AIDS and tuberculosis, most recently under the supervision of infectious disease specialist and the founder of Liverpool VCT Centre in Kenya, Dr. Miriam Taegtmeyer.</p>\n<p>\n  </p>\n<p>\n Her initial experience in research was at the Kenya Medical Research Institute, Center for Geographic Medical Research-Wellcome Trust (Kilifi, Kenya). This led to 3 years experience as a Research Medical Doctor and ‘Project Manager, with the KEMRI/Wellcome-Trust, pneumococcal epidemiology surveillance team. She led the first adult study at KEMRI/WT that investigated the incidence of invasive bacterial diseases in adult in-patients’ at the Kilifi District Hospital.</p>\n<p>\n  </p>\n<p>\n She also gained international research experience while completing a Master’s dissertation towards the fulfillment of a degree in Masters’ of Science in Global Health at the University of Oxford (UK). The Masters ‘research project was carried out at the University of Colombo, Sri Lanka.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <u>Lazarus Odeny</u></p>\n<p>\n <strong><u>Position: Senior Data Manager</u></strong></p>\n<p>\n He holds the position of TB branch Senior Data Manager</p>\n<p>\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>\n He has held the following positions:</p>\n<p>\n  </p>\n<p style=\"margin-left:.25in;\">\n 1.    Senior Data Analyst and Data manager – <strong>KEMRI/CDC</strong></p>\n<p style=\"margin-left:.25in;\">\n 2.    Senior Data manager – International Centre for Reproductive Health (<strong>ICRH</strong>)</p>\n<p style=\"margin-left:.25in;\">\n 3.    Data manager – <strong>KEMRI/CDC</strong></p>\n<p>\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>\n  </p>\n<p>\n <u>Hyrine Matheka</u></p>\n<p>\n <strong><u>Quality Assurance Manager</u></strong></p>\n<p>\n  </p>\n<p>\n She holds the position of QA manager since 2008 in the TB research branch.</p>\n<p>\n  </p>\n<p>\n A graduate of the University of Nairobi in Bachelor of Arts (Economics and Sociology), she graduated in 2007 and she is currently pursuing a <strong>Masters in Arts (project planning and management). </strong>Her previous research experience was as a regulatory affairs volunteer at the Walter Reed Project (USAMRU<strong>-Kenya). </strong></p>\n<p>\n  </p>\n<p>\n The position of Quality Assurance (QA) in the TB research branch has allowed her 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.</p>\n<p>\n  </p>\n<p>\n 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>\n  </p>\n<p>\n She has gained relevant trainings and skills during her research experience which include:  Good Clinical Practice, trial site management as a study coordinator, trial site management as a study monitor (CRA), ethical aspects in clinical research, and epidemiology and biostatistics; all trainings were offered by the Vienna School of Clinical Research (VSCR). She has also had internal auditor training (ISO 9000: 2008) plus its implementation process. This training was offered by the Kenya Bureau of Standards.</p>\n<p>\n  </p>\n<p>\n <u>Dr. Victor Mudhune</u></p>\n<p>\n <strong><u>Position: Clinical Trials Pharmacist</u></strong></p>\n<p>\n  </p>\n<p>\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>\n  </p>\n<p>\n His major duties as a clinical trials pharmacist include:</p>\n<p style=\"margin-left:.25in;\">\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-left:.25in;\">\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-left:.25in;\">\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-left:.25in;\">\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-left:.25in;\">\n 5.    Maintaining the blinding of the participant’s treatment assignment to investigators, study nurses, clinic staff and participant.</p>\n<p style=\"margin-left:.25in;\">\n 6.    Maintaining the confidentiality of the participant, participant’s pharmacy file and the study drug/placebo accountability record.</p>\n<p style=\"margin-left:.25in;\">\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-left:.25in;\">\n 8.    Ensuring the security of all documents and investigational drug/placebo.</p>\n<p style=\"margin-left:.25in;\">\n 9.    Preparing pharmacy related standard operating procedures ensuring they meet GCP, NIH and other regulatory requirements.</p>\n<p style=\"margin-left:.25in;\">\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-left:.25in;\">\n 11.  Providing overall supervision to senior TB branch staff on pharmacy related activities.</p>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<p>\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>\n  </p>\n<p>\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>\n  </p>\n<p>\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>\n  </p>\n<p>\n <u>Albert Ochieng Okumu</u></p>\n<p>\n <strong><u>Position: Laboratory Manager </u></strong></p>\n<p>\n  </p>\n<p>\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>\n  </p>\n<p>\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>\n  </p>\n<p>\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>\n  </p>\n<p>\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>\n  </p>\n<p>\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>\n  </p>\n<p>\n <u>Janet Agaya</u></p>\n<p>\n <strong><u>Position: Study Coordinator Tuberculosis Trials Consortium (TBTC) study</u></strong></p>\n<p>\n  </p>\n<p>\n She holds the position of study coordinator in the Tuberculosis Trials Consortium (TBTC) study</p>\n<p>\n  </p>\n<p>\n She is has worked previously as a Public Health officer at the Ministry of Health, Kenya and holds a Masters degree in Public Health. She has participated in many research projects in different capacities with products in reports, published and unpublished papers.</p>\n<p>\n  </p>\n<p>\n She has successfully coordinated TB studies in KEMRI/CDC including TB prevalence surveys from 2005 to date. This has involved management of field activities for several TB research studies and working with people from different communities and cultural backgrounds.</p>\n<p>\n  </p>\n<p>\n She has received training that is relevant to her work in research and this includes: Good Clinical Practice, Scientific Writing, Epidemiology, Research Ethics, Health Behavior and Education for Community Health Workers.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <u>Benard Owuor</u></p>\n<p>\n <strong><u>Position: TB branch Administrative Manager</u></strong></p>\n<p align=\"left\">\n  </p>\n<p align=\"left\">\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\">\n  </p>\n<p align=\"left\">\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\">\n  </p>\n<p>\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<p>\n  </p>\n
      • other_details_explanation<p>\n The trial will be conducted in the host country and in 8 other countries including Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n CDC IRB initial approval: 19th Jan 2011</p>\n<p>\n continuation: 1st April 2011, 21st March 2013</p>\n<p>\n  </p>\n<p>\n KEMRI ERC initial approval: 13th July 2011</p>\n<p>\n continuation: 11th July 2012 </p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard Intensive Phase
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/CDC-KISUMU
      • single_site_physical_addressPO BOX 1578-40100, Kisumu, Kenya
      • single_site_contact_personDr Lena Matata
      • single_site_telephone+254700111398
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states9
      • number_of_sites
      • multi_country_listUSA, BRAZIL, SPAIN, PERU, HONG KONG, VIETNAM, SOUTH AFRICA, UGANDA, KENYA
      • data_monitoring_committeeYes
      • total_enrolment_per_siteupto 50
      • total_participants_worldwide320
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElisha
      • investigator1_middle_name
      • investigator1_family_nameOkeyo
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKEMRI-CDC, PO BOX 1578-40100, Kisumu
      • investigator1_telephone+254721410654
      • investigator1_emailEokeyo@kemricdc.org
      • organisations_transferred_Yes
      • number_participantsupto 50
      • notification<p>\n None</p>\n
      • approval_date02-11-2011
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-07-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n <strong><u>EXECUTIVE SUMMARY</u></strong></p>\n<p>\n One-third of the world population is infected with <em>Mycobacterium tuberculosis</em> (MTB). Eighty percent of all TB cases occur in the 22 high burden countries of which Kenya is ranked 15^th. According to the WHO, in the year 2012, 8.6 million people were diagnosed with the disease, leading to 1.3 million deaths including 320,000 HIV infected persons. While effective chemotherapy is available for drug susceptible MTB, lengthy treatment periods increase the likelihood of defaulting treatment. Newer, effective drugs and shorter treatment regimens will aid in lowering infection rates prevent spread of the disease.</p>\n<p>\n The KEMRI/CDC Research and Public Health Collaboration joined the CDC Tuberculosis Trials Consortium (TBTC) in 2009.  TBTC study 29X, was the first drug trial done in collaboration with the consortium at KEMRI/CDC Kisumu. The protocol aimed to evaluate the safety, tolerability, efficacy and antimicrobial activity of the doses of a TB treatment regimen comprised of rifapentine (either 15mg/kg/dose or 20mg/kg/dose) + isoniazid + pyrazinamide + ethambutol compared to the standard intensive phase TB regimen rifampin (10mg/kg/dose) + isoniazid + pyrazinamide + ethambutol.  The study also determined and compared the culture conversion rate of each regimen using data from week 2, 4, 6 and 8 cultures. Study recruitment was at Jaramogi Oginga Odinga teaching and Referral hospital (JOOTRH) and follow up was done at the KEMRI/CDC Clinical Research site adjacent to JOOTRH.</p>\n<p>\n KEMRI/CDC Kisumu began enrolling on 24^th January 2012 and the last participant was enrolled on the 4^th of October 2012. The screening enrollment numbers for the study are as follows; 76 participants were screened and 28 out of these were enrolled. 22 of the 28 participants were randomized to receive Rifapentine and 6 to receive Rifampin, 3 of the 28 were HIV positive. Globally 334 participants were enrolled (56.9%) were enrolled at African sites, 26/334 (7.8%) had HIV.</p>\n<p>\n  </p>\n<p>\n Percentages of participants discontinuing assigned treatment were significantly below the pre-specified rate of 30% for each arm At completion of intensive phase, cultures on solid media were negative in 81.3% of participants in the rifampin group versus 92.5% (p=0.097), 89.4% (p=0.29), and 94.7% (p=0.049) in the rifapentine 10, 15, and 20 mg/kg groups.  Liquid cultures were negative in 56.3% (rifampin group) versus 74.6% (p=0.042), 69.7% (p=0.16), and 82.5% p=0.004), respectively.  Compared with the rifampin group, the proportion negative at the end of intensive phase was higher among rifapentine recipients who had high rifapentine AUCs</p>\n<p>\n  </p>\n<p>\n <strong>Conclusions:</strong> High-dose daily rifapentine was well-tolerated and safe.  High rifapentine exposures were associated with very high levels of sputum sterilization at completion of intensive phase.  A phase 3 trial is warranted to determine if regimens that deliver high rifapentine exposures can shorten TB treatment duration to less than 6 months</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-08-03 12:32:03
      • created2013-03-26 14:21:05
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id62
        • application_id75
        • given_nameLena
        • middle_name
        • family_nameMatata
        • qualificationMedical Doctor
        • professional_addressKEMRI-CDC PO BOX 1578-40100, Kisumu
        • telephone+254700111398
        • emailLmatata@kemricdc.org
        • created2013-04-05 11:16:35
        • modified2013-07-31 11:05:27
      • 1(array)
        • id63
        • application_id75
        • given_nameKevin
        • middle_name
        • family_nameCain
        • qualificationMedical Doctor
        • professional_addressKEMRI-CDC, PO BOX 1578-40100 Kisumu
        • telephone+254710602786
        • emailKCain@ke.cdc.gov
        • created2013-04-05 11:16:48
        • modified2013-07-31 11:05:27
    • SiteDetail(array)
      • 0(array)
        • id84
        • application_id75
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-04-05 11:16:35
        • modified2013-07-31 11:05:27
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id48
        • application_id75
        • sponsorDivision of Tuberculosis Elimination (Tuberculosis Trials Consortium)-CDC
        • sponsor_type(null)
        • contact_personDr. Stefan Goldberg
        • addressCenters for Disease Control and Prevention 1600 Clifton Rd Atlanta, GA 30333
        • telephone_number404.639.8239
        • fax_number404.639.8961
        • cell_number+14046395339
        • email_addressssg3@cdc.gov
        • created2013-04-05 11:16:35
        • modified2013-07-31 11:05:27
  • 1(array)
    • Application(array)
      • id203
      • user_id94
      • trial_status_id5
      • abstract_of_study<p>\n The SSG/PM (Sodium Stibogluconate/Paromycin) Pharmacovigilance Plan aims to collect pharmacovigilance information during the early post-approval period of SSG/PM as soon as SSG/PM is in use by the Ministries of Health for treatment of Visceral Leishmaniasis.</p>\n<p>\n During the early post-approval period, SSG/PM might be used in settings different from clinical trials and a much larger and diverse population might be exposed in a relatively short timeframe. The pharmacovigilance (PV) programme is crucial in order to continuously evaluate the risk-benefit ratio in different groups of patients and in different contexts</p>\n<p>\n The Pharmacovigilance study in Kenya involves the key sentinel site of Kacheliba kala-azar treatment centre and Kimalel, (where MSF-OCG is based). A similar protocol is ongoing in Sudan and planned for Uganda. The Pharmacovigilance plan primary objectives are: a) to continuously monitor the safety profile of SSG/PM during the first 2 years that follow its authorization for use in East Africa; b) to identify additional risks that have not been reported in pre-approval clinical studies; c) to determine whether SSG/PM adverse reactions are of higher concern in specific groups of patients; d) to monitor the treatment failure rate of SSG/PM and e) to monitor any evidence in site variation in terms of SSG/PM effectiveness and safety.</p>\n<p>\n The target population are all VL patients treated with SSG/PM in Kenya and other participating countries. A registry is used independently from clinical presentation and demographic characteristics. Diagnostic, treatment and discharge procedures should be consistent with the routine clinical practice in use in the health facility. A standard form is used to collect information. No blood/tissue samples or extra medical procedures are required for the PV plan.</p>\n<p>\n Every 3 months, descriptive statistics are produced. In particular, the total number of SAE, the number of treatment-related SAE and the number of treatment failures are calculated. The Steering Committee is responsible for data review.</p>\n<p>\n In Kenya Ethical and Regulatory approval is sought through KEMRI ERC and Pharmacy and Poisons Board. Informed consent document is distributed to each patient treated with SSG/PM. The aim of the PV plan is discussed, as well as the measures taken to ensure confidentiality of the data collected.</p>\n<p>\n Ultimately, the information generated through PV plan will help refine VL management guidelines and assist physicians in choosing the best treatment. The PV plan also will be used as the risk management plan for introduction of the SSG/PM Combination for treatment of VL.</p>\n
      • study_title<p>\n <strong>Pharmacovigilance Plan to Monitor the Safety and Effectiveness of Combination of Sodium Stibogluconate and Paramomycin in the Treatment of Visceral Leishmaniasis</strong></p>\n<p>\n The SSG/PM (Sodium Stibogluconate/Paromycin) Pharmacovigilance Plan aims to collect pharmacovigilance information during the early post-approval period of SSG/PM as soon as SSG/PM is in use by the Ministries of Health for treatment of Visceral Leishmaniasis.</p>\n<p>\n During the early post-approval period, SSG/PM might be used in settings different from clinical trials and a much larger and diverse population might be exposed in a relatively short timeframe. The pharmacovigilance (PV) programme is crucial in order to continuously evaluate the risk-benefit ratio in different groups of patients and in different contexts</p>\n<p>\n The Pharmacovigilance study in Kenya involves the key sentinel site of Kacheliba kala-azar treatment centre, (where MSF-OCG is based). A similar protocol is ongoing in Sudan and planned for Uganda. The Pharmacovigilance plan primary objectives are: a) to continuously monitor the safety profile of SSG/PM during the first 2 years that follow its authorization for use in East Africa; b) to identify additional risks that have not been reported in pre-approval clinical studies; c) to determine whether SSG/PM adverse reactions are of higher concern in specific groups of patients; d) to monitor the treatment failure rate of SSG/PM and e) to monitor any evidence in site variation in terms of SSG/PM effectiveness and safety.</p>\n<p>\n The target population are all VL patients treated with SSG/PM in Kenya and other participating countries. A registry is used independently from clinical presentation and demographic characteristics. Diagnostic, treatment and discharge procedures are consistent with the routine clinical practice in use in the health facility. A standard form is used to collect information. No blood/tissue samples or extra medical procedures are required for the PV plan.</p>\n<p>\n Every 3 months, descriptive statistics are produced. In particular, the total number of SAE, the number of treatment-related SAE and the number of treatment failures are calculated. The Steering Committee is responsible for data review.</p>\n<p>\n In Kenya Ethical and Regulatory approval is sought through KEMRI ERC and Pharmacy and Poisons Board. Informed consent document is distributed to each patient treated with SSG/PM. The aim of the PV plan is discussed, as well as the measures taken to ensure confidentiality of the data collected.</p>\n
      • laymans_summary(null)
      • short_titleSSG/PM Pharmacovigilance Plan
      • protocol_noECCT/11/08/04
      • version_noVersion 1, dated 24 May 2012_Kenya
      • date_of_protocol24-05-2012
      • study_drugCombination Sodium Stibogluconate and Paramomycin
      • disease_conditionPrimary Visceral Leishmaniasis in East Africa
      • 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_namePentavalent Antimonial and Aminoglycoside Antibiotic
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjmalongo@dndi.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_applicantDr. Robert Kimutai
      • declaration_date121-08-2013
      • declaration_principal_investigatorDr. Monique Wasunna
      • declaration_date221-08-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n All patients treated with SSG/PM combination</li>\n <li>\n All patients who give written informed consent for data collection and inclusion in the registry</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Concurrent treatment with an aminoglycoside</li>\n <li>\n Severe renal, cardiac or liver disease</li>\n <li>\n Known hypersensitivity reactions to either of the treatments</li>\n</ol>\n<p>\n Patients who do not consent to data collection will be treated with SSG/PM according to the Ministry of Health guidelines unless specifically contraindicated. Any side effects will be reported through the Ministry of Health National Pharmacovigilance System if the patients are not in the study.</p>\n
      • primary_end_points<ol>\n <li>\n To continuously monitor the safety profile of SSG/PM during the first 2 years that follow its authorization for import and use in East Africa</li>\n <li>\n To identify additional risks that have not been reported in pre-approval clinical studies</li>\n <li>\n To determine whether SSG/PM adverse reactions are of higher concern in specific groups of patients</li>\n <li>\n To monitor the treatment failure rate of SSG/PM</li>\n <li>\n To monitor any evidence in site variation in terms of SSG/PM effectiveness and safety</li>\n</ol>\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_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The sites are Ministry of Health sites which treat Kala azar. The Kimalel and Kacheliba site have Kala azar diagnostic and treatment capacity.</p>\n
      • other_details_explanation<p>\n The pharmacovigilance study population are the patients treated for Kala azar on a routine basis at the health centre. The study is not a trial.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states12
      • number_of_sites2
      • multi_country_listEthiopia, Sudan, Uganda
      • data_monitoring_committeeYes
      • total_enrolment_per_siteBased on patients treated. Approximately 600.
      • total_participants_worldwideEstimated 3000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • 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_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren under treatment for Kala azar. Parents give consen
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMonique
      • investigator1_middle_name
      • investigator1_family_nameWasunna
      • investigator1_qualificationMBChB, MSc, PhD, DTM&H, DLSHTM, FRSTMH
      • investigator1_professional_addressP.O. Box 20778 KNH 00202 Nairobi
      • investigator1_telephone+254202077767
      • investigator1_emailafrica@dndi.org
      • organisations_transferred_No
      • number_participantsNo sample size calculations required for this pharmacovigilance study. Sentinel sites used
      • notification
      • approval_date13-05-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-09-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The Sodium Stibogluconate/ Paromomycin Pharmacovigilance Plan (SSG/PM PV Plan) was developed in 2010 for risk management during the early post-approval period of SSG/PM as soon as the drugs were in use by the Ministries of Health for the treatment of Visceral Leishmaniasis (VL). In 2010 WHO recommended SSG/PM combination as first line treatment for VL patients in Eastern Africa.<br />\n The PV plan was crucial to continuously evaluate the risk-benefit ratio in different groups of patients and in different contexts. The PV plan objectives were to continue to monitor the safety profile of SSG/PM during the first 2 years that followed its authorization for use in East Africa, identify additional risks that had not been reported in pre-approval clinical studies, determine whether SSG/PM adverse reactions were of higher concern in specific groups of patients, monitor the treatment failure rate of SSG/PM and document any evidence of site and geographical variation in terms of SSG/PM effectiveness and safety.<br />\n Regulatory approval was obtained in Sudan, Kenya, Uganda and Ethiopia to implement the PV plan. Twelve VL treatment Centres from Ministry of Health, Drugs for Neglected Diseases Initiative (DNDi) and Medecins Sans Frontieres (MSF) sponsored sites were involved. A common safety registry was developed. The sites were trained on active PV data collection and consenting of patients for data collection. Periodic Safety Updates Reports were reviewed by a steering committee and submitted to regulatory authorities.<br />\n A total of 3126 patients were enrolled in the PV plan. Majority of the patients were from Sudan n = 1962 (62.7%). Kenya enrolled 652 (20.9%) patients, Ethiopia and Uganda 322 (10.3%) and 190 (6.1%) respectively. Overall effectiveness at the end of treatment was 95% and an overall mortality rate was 0.9% (n=27). 1063 (34%) patients had at least one AE during treatment and 62 (2%) SAE’s or unexpected AE’s were reported. There were no Suspected Unexpected Serious Adverse Reactions (SUSARS) reported.<br />\n The conclusion from the PV plan was that findings supported the use of SSG/PM as first line treatment for VL in East Africa according to WHO recommendations. SSG/PM showed high effectiveness, low failure rate, low mortality rate and importantly there were no new safety concerns. SSG/PM should however be used with caution in patients who have relative contraindications namely older patients and HIV/VL co-infection.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-11-15 10:11:46
      • created2013-08-12 14:26:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id134
        • application_id203
        • given_nameMonique
        • middle_name
        • family_nameWasunna
        • qualificationMBChB, MSc, PhD, DTM&H, DLSHTM, FRSTMH
        • professional_addressP.O. Box 20778 KNH 00202 Nairobi
        • telephone+254202077767
        • emailafrica@dndi.org
        • created2013-08-12 14:30:53
        • modified2013-09-13 17:32:36
    • SiteDetail(array)
      • 0(array)
        • id167
        • application_id203
        • county_id24
        • site_nameKacheliba Kala-azar treatment centre
        • physical_addressKacheliba
        • contact_detailsP.O. Box 63 Kapenguria
        • contact_personHarrison Kuboka
        • site_capacity(null)
        • misc(null)
        • created2013-08-12 14:30:53
        • modified2013-09-13 17:32:36
        • County(array)
          • id24
          • county_nameWest Pokot
          • created2012-06-15 10:24:52
          • modified2012-06-15 10:24:52
      • 1(array)
        • id170
        • application_id203
        • county_id30
        • site_nameKimalel Health Centre
        • physical_addressBaringo
        • contact_detailsP.O. Box 139, Marigat
        • contact_personDr. Monique Wasunna
        • site_capacity(null)
        • misc(null)
        • created2013-08-21 11:54:08
        • modified2013-09-13 17:32:36
        • County(array)
          • id30
          • county_nameBaringo
          • created2012-06-15 10:25:39
          • modified2012-06-15 10:25:39
    • Sponsor(array)
      • 0(array)
        • id108
        • application_id203
        • sponsorMédecins Sans Frontieres
        • sponsor_type(null)
        • contact_personDr. F. Chappuis
        • addressCP 116, 1211 Geneva 21, Switzerland
        • telephone_number+41 22 849 8400
        • fax_number
        • cell_number+41-22-3729620.
        • email_addressFrancois.Chappuis@hcuge.ch
        • created2013-08-12 14:30:53
        • modified2013-09-13 17:32:36
      • 1(array)
        • id111
        • application_id203
        • sponsorDrugs for Neglected Diseases initiative, DNDi
        • sponsor_type(null)
        • contact_personDr. Jorge Alvar
        • addressDNDi, Chemin Louis Dunant, 15, 1202 Geneva, Switzerland
        • telephone_number+41229069230
        • fax_number
        • cell_number+41 79 701 99 89
        • email_addressManica.BALASEGARAM@geneva.msf.org
        • created2013-08-21 11:30:39
        • modified2013-09-13 17:32:36
  • 2(array)
    • Application(array)
      • id200
      • user_id67
      • trial_status_id8
      • abstract_of_study<p>\n Oral candidiasis (OC) is among the most common opportunistic infections observed in HIV infected individuals. OC tends to occur in about 60%of patients with a CD4+T-cell count of <200cells/mm³and of these, more than half experience recurrence. Current criteria in the choice of treatment for OC is determined by availability and affordability of medications within a particular clinical setting or based on specified institutional or national guidelines. Kenya’s Ministry of Health guideline on management of OC recommends use of Gentian violet (0.5-1%), nystatin oral suspension, and clotrimazole cream while fluconazole and ketoconazole is recommended for systemic therapy when there is no improvement with topical preparations.   Gentian violet (GV) 0.5-1% has been used; though rarely due to stigma of discoloration of the oral cavity despite GV being cheaper, easy to use and store.  This study compares the safety and efficacy of topical GV (0.00165%) to that of oral nystatin suspension. HIV-1 positive participants’ ≥ 18 years of age will be randomized to receive either topical GV solution (5 mL swish and gargle for 2 minutes and spit BID) or nystatin oral suspension (5 mL swish for 2 minutes and swallow QID) for 14 days. Therapy will be considered as failed if participants have no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Evaluation of signs and symptoms of OC will be done by an evaluator who is blinded to the treatment assignment. Participants who are failing treatment after the study-defined 14-day treatment regimen will be referred to their primary physician for care and treatment outside of the study, but will continue to be followed on study. Quantification of Colony Forming Units (CFUs) of <em>Candida </em>species (ssp.) and assessment of the emergence of resistance will be performed using an oropharyngeal swab and a second specimen from oral rinse will be collected and stored for future testing.The Kericho site will recruit about 40-80  participants who present with OC as evidenced by pseudomembranous candidiasis. Recruitment will be primarily done through Kericho District Hospital HIV clinic. All enrolled participants will be followed up for 13 weeks. The site accrual rate is estimated to be 10 participants per month; hence estimated duration of accrual is 4-8months. If GV is shown to be superior to nystatin in the treatment of OC, an effective low-cost therapy would then be readily available to patients who cannot afford more expensive therapy. This may be particularly relevant in resource-limited settings where the cost of therapy poses a serious challenge for patients as well as for treating physicians.</p>\n
      • study_title<p>\n A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Topical Gentian Violet to that of Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-1 Infected Participants in Non-U.S. Settings</p>\n
      • laymans_summary<p>\n Oral candidiasis (OC) is among the most common opportunistic infections observed in HIV infected individuals. This study compares the safety and efficacy of topical GV (0.00165%) to that of oral nystatin suspension. HIV-1 positive participants’ ≥ 18 years of age will be randomly assigned to receive either topical GV solution (5 mL swish and gargle for 2 minutes and spit BID) or nystatin oral suspension (5 mL swish for 2 minutes and swallow QID) for 14 days. Therapy will be considered as failed if participants have no clinical improvement (assessed by severity of  candidiasis) during either treatment regimen.</p>\n
      • short_titleCompare the Efficacy and Safety of Gentian Violet to that of Nystatin
      • protocol_noECCT/11/08/03
      • version_noversion 1.0
      • date_of_protocol19-03-2010
      • study_drugTopical Gentian Violet
      • disease_conditionOropharyngeal Candidiasis
      • 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_nameGentian Violet
      • product_type_medical_device_name
      • comparatorYes
      • comparator_namenystatin
      • comparator_registeredyes
      • comparator_countriesKenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdeborah.langat@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDeborah C. Langat
      • declaration_date130-07-2013
      • declaration_principal_investigatorSamuel K. Sinei
      • declaration_date230-07-2013
      • placebo_presentNo
      • study_objectives<p>\n Primary Objective</p>\n<p>\n 1. To evaluate the clinical efficacy of topical GV solution compared to nystatin oral suspension in the treatment of OC, as evidenced by pseudomembranous candidiasis, in HIV-infected adult participants.</p>\n<p>\n Secondary Objectives</p>\n<p>\n 1.       To evaluate symptoms associated with OC at entry, end of treatment, and at clinical relapse.</p>\n<p>\n 2.       To evaluate quantitative yeast colony counts at entry, end of treatment, week 6, and at clinical relapse.</p>\n<p>\n 3.       To evaluate the effect of strata (baseline CD4+ T-cell count and ART) on clinical efficacy.</p>\n<p>\n 4.       To assess the emergence, if any, of fungal resistance in the treatment arms.</p>\n<p>\n 5.       To evaluate the safety of GV and nystatin in the treatment of OC.</p>\n<p>\n 6.       To evaluate participant tolerance, adherence, health self-assessment, and acceptability of GV and nystatin.</p>\n<p>\n 7.       To perform a cost analysis comparing the strategies of no treatment, treatment with nystatin, and treatment with GV for OC based on clinical efficacy as established by the trial and country-specific cost data.</p>\n<p>\n 8.       To create a specimen repository of oral rinse, serum, plasma, and Candida isolates that can be a resource for other AIDS Clinical Trials Group (ACTG) and Oral HIV/AIDS Research Alliance (OHARA) investigators.</p>\n<p>\n To compare clinical and mycological outcomes (clinical efficacy, quantitative yeast counts, and emergence of fungal resistance) in those with Karnofsky score ≥ 60 and those <60.</p>\n
      • principal_inclusion_criteria<p>\n 1.      HIV-1 infection, documented by any licensed rapid HIV test or HIV   enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p>\n 2.      Pseudomembranous candidiasis documented by a complete oral exam (i.e., white or yellow spots or plaques with an underlying erythematous base that may be located in any part of the oral cavity) at the screening visit.</p>\n<p>\n NOTE: Participants with documented angular chelitis and/or erythematous candidiasis without pseudomembranous candidiasis are not eligible to enroll in the study.</p>\n<p>\n 3.      Direct microscopic examination (KOH or Gram-stained smear) consistent with <em>Candida</em> spp. at screening and evidence of pseudomembranous candidiasis within 21 days prior to study entry.</p>\n<ol>\n <li value=\"4\">\n If currently being treated with an ART regimen, initiation of regimen at least 12 weeks prior to study entry, and willingness of participant to remain on current ART regimen until the study-defined 14-day treatment period is complete.</li>\n</ol>\n<p>\n             NOTE: Participants who are not ART-naïve and not on ART are eligible to participate in</p>\n<p>\n             the study if they do not intend to initiate ART during the Study- defined 14-day treatment    </p>\n<p>\n             period.</p>\n<p>\n 5.      CD4+ cell count obtained within 30 days prior to study entry at a DAIDS- approved laboratory.</p>\n<p>\n 6.      Laboratory values obtained within 7 days prior to study entry:</p>\n<p style=\"margin-left:1in;\">\n Absolute neutrophil count (ANC) ³ 750/mm³</p>\n<p style=\"margin-left:1in;\">\n Hemoglobin ³ 7.0 g/dL</p>\n<p style=\"margin-left:1in;\">\n Platelet count ³ 50,000/mm³</p>\n<p style=\"margin-left:1in;\">\n Creatinine £ 3 ´ upper limit normal (ULN)</p>\n<p style=\"margin-left:1in;\">\n Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), and alkaline phosphatase £ 5 ´ ULN</p>\n<p style=\"margin-left:1in;\">\n Total bilirubin £ 2.5 ´ ULN</p>\n<p style=\"margin-left:1in;\">\n Serum glucose < 200 mg/dL (fasting not required)</p>\n<p>\n 7.      Female study volunteers of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months [i.e., who have had menses within the preceding 24 months], or have not undergone surgical sterilization [e.g., hysterectomy, bilateral oophorectomy, or salpingotomy]) must have a negative serum or urine pregnancy test (a sensitivity of at least 50mIU/mL) performed within 48 hours prior to study entry.</p>\n<p>\n 8.      If participating in sexual activity that could lead to pregnancy, the female study volunteer must use at least one form of contraceptive while receiving protocol-specified medication(s) and for 1 month after stopping the medications:</p>\n<p style=\"margin-left:1in;\">\n Condoms (male or female) with or without a spermicidal agent. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission.</p>\n<p style=\"margin-left:1in;\">\n Diaphragm or cervical cap with spermicide</p>\n<p style=\"margin-left:1in;\">\n Intrauterine device (IUD)</p>\n<p style=\"margin-left:1in;\">\n Hormone-based contraceptive</p>\n<p>\n If the female volunteer is not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or women who have undergone surgical sterilization [e.g., hysterectomy, bilateraloophorectomy, or salpingotomy]), she is eligible without requiring the use of a contraceptive. Acceptable documentation of sterilization, other contraceptive methods, and menopause is participant-reported history.</p>\n<p>\n 9.      Karnofsky performance score ≥ 30 at study screening.</p>\n<p style=\"margin-left:38.15pt;\">\n NOTE: Subject must be able to take the medication with or without assistance.  Subject  must be able to swish, gargle, and expectorate or swish and swallow as instructed.</p>\n<p>\n 10.  Men and women age ³ 18 years.</p>\n<p>\n 11.  Ability and willingness of participant to provide informed consent and to attend all planned study visits.</p>\n
      • principal_exclusion_criteria<p>\n 1.      Documented or presumptive signs or symptoms of esophageal candidiasis (e.g., dysphagia) during the screening period unless endoscopic examination of the esophagus was performed and fungal esophagitis were excluded.</p>\n<p>\n 2.      Use of any investigational drug currently or within 30 days prior to study entry.</p>\n<p>\n NOTE: For purposes of this study, drugs available under an FDA-authorized expanded access program will NOT be considered investigational.</p>\n<p>\n 3.      Concurrent vaginal candidiasis within 21 days prior to study entry.</p>\n<p>\n NOTE: Participant complaints and pelvic exam, if needed, will be used to</p>\n<p>\n             determine vaginal candidiasis. If vaginal candidiasis is detected,</p>\n<p>\n             participants will be referred for care accordingly.</p>\n<p>\n 4.      Use of inhaled or systemic corticosteroids within 14 days prior to study entry.</p>\n<p>\n 5.      Use of any antifungal agents within 14 days prior to study entry.</p>\n<p>\n NOTE: Antibacterials, antivirals (non-ART), and antimycobacterials for treatment or prophylaxis of other conditions/opportunistic infections are permitted.</p>\n<p>\n 6.      Anticipate need for systemic or oral/topical antifungal agents for other diagnoses within the study-defined 14-day treatment period.</p>\n<p>\n 7.      Intend to initiate ART during the screening period, at study entry, or within the study-defined 14-day treatment period.</p>\n<p>\n 8.      Intend to use any additional oral topical treatments within the study-defined 14-day   treatment period.</p>\n<p>\n 9.      Known allergy/sensitivity or any hypersensitivity to components of study              drugs or their formulation.</p>\n<p>\n 10.  Active drug or alcohol use or dependence that, in the opinion of the site      investigator, would interfere with adherence to study requirements.                   </p>\n<p>\n 11.  Serious illness, in the opinion of the site investigator, requiring systemic    treatment.</p>\n<p>\n 12.  Previous or current history of porphyria.</p>\n<p>\n 13.  Presence of oral warts during the screening period or the day of study entry before randomization.</p>\n<p>\n 14.  Current wearing of full dentures or a maxillary partial denture at study entry.</p>\n
      • primary_end_points<p>\n 1. Clinical efficacy</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_pharmacoecomomic1
      • 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 <strong>A) Site Principal Investigator</strong></p>\n<p>\n  Prof Samuel Sinei, MBChB, MMED</p>\n<p>\n Deputy Director Program Operations</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: (+254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 727 531396</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:ssinei@wrp-kch.org\">samuel.sinei@usamru-k.org</a></p>\n<p>\n <strong>B) Co- Principal Investigator,</strong></p>\n<p>\n Dr Fredrick Sawe, MBChB, MMED</p>\n<p>\n Deputy Director, HIV Research and Treatment</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 724 255623</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">fredrick.sawe@usamru-k.org</a></p>\n<p>\n C) <strong>Associate Investigator,</strong></p>\n<p>\n Dr Deborah Langat, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 714 059596</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:dchepngeno@wrp-kch.org\">Deborah.langat@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n Dr Fredrick Kirui, MBChB, MMED</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n  P.O. Box 1357 - 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel +254-52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531373</p>\n<p>\n Fax: + 254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:fkkirui@wrp-kch.org\">fredrick.kirui@usamru-k.org</a>.</p>\n<p>\n Dr Josphat Kosgei, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 - 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 729 110122</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">Josphat.kosgei@usamru-k.org</a>.</p>\n<p>\n  </p>\n<p>\n Dr Kathleen Rono, MBchB, MPH & TM</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">Kathleen.rono@usamru-k.org</a>.</p>\n<p>\n  </p>\n<p>\n Dr Lilian Apadet Osamong, Bachelor of Dental Surgery</p>\n<p>\n Kenya Medical Research Institute</p>\n<p>\n P.O. Box 60309 - 00200,</p>\n<p>\n Nairobi, Kenya</p>\n<p>\n Mobile: +254 721 513477</p>\n<p>\n Email: <a href=\"mailto:apadet@yahoo.com\">apadet@yahoo.com</a></p>\n<p>\n Ignatius Kiptoo, BSc, MS</p>\n<p>\n Kenya Medical Research Institute/Walter Reed</p>\n<p>\n Project HIV Program Information Technology</p>\n<p>\n Department Head,</p>\n<p>\n P.O. Box 1357 - 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile phone: +254 727 531375</p>\n<p>\n  Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n E-mail: <a href=\"mailto:Ignatius.kiptoo@usamru-k.org\">Ignatius.kiptoo@usamru-k.org</a></p>\n<p>\n <strong>D) Head of Microbiology</strong>,</p>\n<p>\n Sheila Chebore, MSc</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 714 058603</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:schebore@wrp-kch.org\">Sheilla.chebore@usamru-k.org</a></p>\n<p>\n <strong>E) Pharmacist,</strong></p>\n<p>\n Dr. Noah Tarus, B Pharm</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 30388</p>\n<p>\n Mobile: +254 713 603222</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:ntarus@wrp-kch.org\">Noah.tarus@usamru-k.org</a></p>\n<p>\n <strong>F) Study Coordinator,</strong></p>\n<p>\n Beatrice Korir, KRCHN, Diploma</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 702 119191Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:bkorir@wrp-kch.org\">Beatrice.korir@usamru-k.org</a></p>\n<p>\n <strong>G) Local Medical Monitors</strong></p>\n<p>\n Dr. Jonah Maswai, MBChB, MPH</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 727531373</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:jmaswai@wrp-kch.org\">Jonah.maswai@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n Dr. Appolonia Aoko, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 715551234</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:aaoko@wrp-kch.org\">Appolonia.aoko@usamru-k.org</a></p>\n<div>\n Please see also page 85 of the Site Specific Addendum Apendix II, KEMRI/WRP Roles of Study</div>\n<div>\n Personnel</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n It is a multicentre study being conducted in non US setting. The drug being investigated is GV which is mainly used in the resource limitted  setting.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KEMRI ERC -  12 Jul 2012</p>\n<p>\n WRAIR IRB - 22 Aug 2012</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS Co-Infections and Complications Data and Safety Monitoring Board (DSMB) met on September 27, 2012, to review interim data for A5265 through July 19, 2012. They recommended that enrollment to the study be immediately halted to allow redesigning of the protocol. See attached memo.</p>\n
      • estimated_durationThe estimated duration of accrual is 10- 12 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyAssessment Blinded
      • design_controlled_comparatorNystatin oral suspension
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites2
      • multi_country_listBotswana, Kenya, Uganda, South Africa, India, Malawi, Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_site40-80
      • total_participants_worldwide494
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBeatrice
      • investigator1_middle_nameM
      • investigator1_family_nameKorir
      • investigator1_qualificationKRCHN, Diploma
      • investigator1_professional_addressKEMRI/ WRP P.O BOX 1357 - 20200 Kericho
      • investigator1_telephone+254 702 119191
      • investigator1_emailBeatrice.korir@usamru-k.org
      • organisations_transferred_Yes
      • number_participants80
      • notification
      • approval_date22-11-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<ol>\n <li>\n <strong>INTRODUCTION:</strong></li>\n</ol>\n<p style=\"margin-left:.5in;\">\n This was a phase III, randomized, open-label, assessment-blinded clinical trial in non-U.S. sites to compare the safety and efficacy of topical GV (0.00165%)  to that of oral nystatin suspension. Male and female HIV-1 positive participants ≥ 18 years of age were randomized with equal probability and stratified by CD4+ T-cell counts (> 200 cells/mm3 or ≤ 200 cells/mm3) to receive either topical GV solution (5 mL swish and gargle for 2 minutes and spit BID) or nystatin oral suspension (5 mL swish for 2 minutes and swallow QID) for 14 days. Therapy was considered as failed if participants had no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Evaluation of signs and symptoms of OC was done by an evaluator who was blinded to the treatment assignment. In Kericho, the protocol was started in Dec 20, 2011, 43 participants were screened and of those screened 29 participants were eligible and were enrolled while 14 were ineligible. The last participant to be enrolled in our site was on Sep 26, 2012. The enrollment to the study was halted, on 01 Oct 2012 in order to address several DSMB recommendations in a new protocol version before restarting enrollment again. The issues, in part, related to their concern about not allowing ART for the 2 weeks of antifungal therapy in light of recent changes in guidelines with higher CD4 thresholds for ART initiation. In addition, there was concern raised about whether subjects enrolled were more ill than the protocol allowed. A notification memo was sent to KEMRI ERC on 01 Nov 2012.The last participant completed follow up in our site on Dec 17, 2012 and internationally the last participant completed follow up on Dec 20, 2012.</p>\n<p style=\"margin-left:.5in;\">\n The study was closed to follow up on 08 Jan 2014 after receiving a memo from protocol team on Study Closure to Patient Follow-up because the sponsor decided not to re-open the study due to study feasibility of the proposed re-design. </p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p>\n  </p>\n<p>\n <strong>2. RESEARCH OBJECTIVES: </strong></p>\n<p>\n  </p>\n<p style=\"margin-left:.25in;\">\n <strong><em><u>Hypothesis</u></em></strong></p>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p style=\"margin-left:.25in;\">\n Topical application of gentian violet (GV) for 14 days is superior to nystatin oral suspension in the treatment of oral candidiasis (OC) in HIV-1 infected participants.</p>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p style=\"margin-left:.25in;\">\n <strong><em><u>Primary Objective</u></em></strong></p>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p style=\"margin-left:.25in;\">\n To evaluate the clinical efficacy of topical GV solution compared to nystatin oral suspension in the treatment of OC, as evidenced by pseudomembranous candidiasis, in HIV-infected adult participants.</p>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p style=\"margin-left:.25in;\">\n <strong><em><u>Secondary</u></em></strong><strong><em><u> Objectives</u></em></strong></p>\n<ol>\n <li>\n To evaluate symptoms associated with OC at entry, end of treatment, and at clinical relapse.</li>\n</ol>\n<p style=\"margin-left:.25in;\">\n  </p>\n<ol>\n <li value=\"2\">\n To evaluate quantitative yeast colony counts at entry, end of treatment, week 6, and at clinical relapse.</li>\n <li value=\"3\">\n To evaluate the effect of strata (baseline CD4+ T-cell count and ART) on clinical efficacy.</li>\n</ol>\n<p style=\"margin-left:.25in;\">\n  </p>\n<ol>\n <li value=\"4\">\n To assess the emergence, if any, of fungal resistance in the treatment arms.</li>\n</ol>\n<p style=\"margin-left:.25in;\">\n  </p>\n<ol>\n <li value=\"5\">\n To evaluate the safety of GV and nystatin in the treatment of OC.</li>\n</ol>\n<p style=\"margin-left:.25in;\">\n  </p>\n<ol>\n <li value=\"6\">\n To evaluate participant tolerance, adherence, self-reported quality of life, and acceptability of GV and nystatin.</li>\n</ol>\n<p style=\"margin-left:.25in;\">\n  </p>\n<ol>\n <li value=\"7\">\n To perform a cost analysis comparing the strategies of no treatment, treatment with nystatin, and treatment with GV for OC based on clinical efficacy as established by the trial and country-specific cost data.</li>\n</ol>\n<p style=\"margin-left:.25in;\">\n  </p>\n<ol>\n <li value=\"8\">\n To create a specimen repository of oral rinse, serum, plasma, and <em>Candida</em> isolates that can be a resource for other AIDS Clinical Trials Group (ACTG) and Oral HIV/AIDS Research Alliance (OHARA) investigators</li>\n</ol>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p>\n <strong>3. SUMMARY OF STUDY RESULTS: </strong></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n The study was closed early per Data Safety Monitoring Board after enrolling 221 participants (target 494) in all international sites. Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the gentian violet arm had cure or improvement of oropharyngeal candidiasis versus 61 (67.8%) in the NYS arm, resulting in a non-sizable difference of 0.007 (95% confidence interval: 0.129, 0.143). There was no sizable difference in cure rates between the two arms (0.0007; 95% confidence interval: 0.146, 0.131). No gentian violet–related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In gentian violet arm, 61 and 39% of participants reported ‘no’ and ‘mild to-moderate’ staining, respectively. Cost for medication procurement was significantly lower for gentian violet versus NYS (median $2.51 and 19.42, respectively, P=0.01).The Study concluded that efficacy of gentian violet was not statistically different than Nystatin (NYS), was well tolerated, and its procurement cost was substantially less than NYS.</p>\n<p>\n  </p>\n<p>\n <strong>4. List publications arising from study (attach copies of the manuscript(s).</strong></p>\n<p>\n  </p>\n<p style=\"margin-left:17.1pt;\">\n Mukherjee PK, Chen H, Patton LL, Evans S, Lee A, Kumwenda J, Hakim J, Masheto  G, Sawe F, Pho MT, Freedberg KA, Shiboski CH, Ghannoum MA, Salata RA; Oral HIVAIDS Research Alliance (OHARA) AIDS Clinical Trials Group (ACTG) 5265 Team. Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants. AIDS. 2017 Jan 2;31(1):81-88.</p>\n<p style=\"margin-left:17.1pt;\">\n  </p>\n<p style=\"margin-left:17.1pt;\">\n  </p>\n<p style=\"margin-left:13.5pt;\">\n <strong>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).</strong></p>\n<p style=\"margin-left:17.1pt;\">\n  </p>\n<p>\n At the Kericho site, each study participant was provided an identification number for study purposes. These study identification numbers were assigned centrally by the Statistical and Data Analysis Center (SDAC) / Data Management Centre (DMC) after the screening log had been entered through the DMC subject enrollment system. 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 all laboratory tests or samples collected and participants study medical records. The study participants’ study documents were stored in Clinical Research Center (CRC) archive room. The CRC archive room is access controlled and secured by triple lock.</p>\n<p>\n  </p>\n<p>\n 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. Access to study documents is controlled and restricted and the site is responsible for ensuring that any access is accurately recorded and any documents accessed/removed and returned are recorded. Destruction approval will be obtained from the sponsor and the IRBs will be notified when this is done.</p>\n<p style=\"margin-left:17.1pt;\">\n  </p>\n<ol>\n <li value=\"5\">\n <strong>Destruction of each study participant’s identifiers and provide an assurance/evidence that the destruction has occurred (send copies of the blacked out books).</strong></li>\n</ol>\n<p>\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 do not have access to this archive room. Access to study documents is controlled and restricted and the site is responsible for ensuring that any access is accurately recorded and any documents accessed/removed and returned are recorded. Destruction approval will be obtained from the sponsor and the IRBs and ECCT will be notified when this is done.</p>\n<p>\n  </p>\n<ol>\n <li value=\"6\">\n <strong>Plan for future use of data from the study (if applicable)</strong></li>\n</ol>\n<p>\n  </p>\n<p>\n Data obtained from the conduct of this study are housed in a secure database maintained by the AIDS Clinical Trials Group Data Management Centre (ACTG DMC). ACTG DMC serves as the central data management facility for ACTG research protocols. Data managed by DMC are entered into and maintained in a password-protected database accessible only to participating A5265 sites, ACTG DMC and Information Technology staff authorized to work on the protocol. The database is located at New York and is protected by a firewall.</p>\n<p>\n 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 DMC will maintain it indefinitely or until there is a regulatory requirement or sponsor instructions to destroy it.</p>\n<p>\n All work for this study is complete. Future use of individually coded data will have to be approved by the IRB.</p>\n<p>\n  </p>\n<ol>\n <li value=\"7\">\n <strong>Confirm destruction of surplus investigational agents and provide an assurance/evidence that the destruction has occurred (if applicable).</strong></li>\n</ol>\n<p>\n This was a non-IND study and study treatment was procured locally. Attached is A5265 Drug Accountability logs.</p>\n<p>\n  </p>\n<p>\n  </p>\n<ol>\n <li value=\"8\">\n <strong>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).</strong></li>\n</ol>\n<p>\n All the samples that were not for safety testing were shipped out with the approval of KEMRI ERC for analysis.</p>\n
      • implication_results(null)
      • quantity_imported0
      • quantity_dispensed16 Gentian Violet, 162 Nystatin
      • quantity_destroyed4 Gentian Violet, 28 Nystatin
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2020-05-20 11:11:17
      • created2013-07-30 12:00:22
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id131
        • application_id200
        • given_nameDeborah
        • middle_nameC
        • family_nameLangat
        • qualificationMBChB, MSC
        • professional_addressKEMRI/ WRP P.O BOX 1357 - 20200 Kericho
        • telephone0522036100
        • emailDeborah.langat@usamru-k.org
        • created2013-07-30 12:57:16
        • modified2020-03-02 18:39:57
    • SiteDetail(array)
      • 0(array)
        • id160
        • application_id200
        • county_id35
        • site_nameKenya Medical Research Institute Walter Reed Project Clinical Research Centre
        • physical_addressHospital Road, Kericho, Kenya
        • contact_detailsTel: +254-52 30686, P.O Box 1357 - 20200
        • contact_personSamuel K. Sinei
        • site_capacity(null)
        • misc(null)
        • created2013-07-30 12:57:16
        • modified2020-03-02 18:39:57
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id161
        • application_id200
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressMoi Teaching Referral Hospital Building, Nandi Road, Eldoret, Kenya
        • contact_detailsP.O. Box 4604 - 30100 Kenya Tel:254-53 2060850
        • contact_personAbraham Mosigisi Siika
        • site_capacity(null)
        • misc(null)
        • created2013-07-30 14:15:57
        • modified2020-03-02 18:39:57
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id105
        • application_id200
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_typeResearch Institution
        • contact_personTrinh Ly
        • addressInternational Research Branch DAIDS, NIAID, NIH 6700-B Rockledge Drive Bethesda, MD 20892-7624
        • telephone_number(301) 402-2297
        • fax_number(301) 480-4456
        • cell_number(301) 402-2297
        • email_addresstly@niaid.nih.gov
        • created2013-07-30 12:57:16
        • modified2020-03-02 18:39:57
  • 3(array)
    • Application(array)
      • id137
      • user_id21
      • trial_status_id8
      • abstract_of_study<div>\n <p>\n <u>DESIGN</u>          In this randomized, open-label, phase IV strategy trial, participants from resource-limited settings (RLS) who present with advanced HIV disease and no probable or confirmed tuberculosis (TB), as defined in the current ACTG diagnosis appendix, and who are initiating antiretroviral treatment (ART) will be randomized to one of two strategy arms: immediate, empiric TB treatment (public health approach) or local standard of care TB treatment (individualized approach). The primary endpoint is survival status in the two arms 24 weeks after randomization. AIDS progression (any new WHO Stage 3 or 4 condition), virologic and CD4+ cell response, HIV and TB drug resistance, AND safety and tolerability of, and adherence to HIV and TB drugs will be evaluated, as will the cost-effectiveness of the two strategies.</p>\n <p>\n <u>DURATION</u>    96 weeks. Participants will transition to locally provided care and treatment at week 48.</p>\n <p>\n <u>SAMPLE SIZE</u>            836 participants</p>\n <p style=\"margin-left: 40px;\">\n <u>POPULATION</u>            HIV-infected antiretroviral-naïve males and females aged 13 years and older, with CD4+ cell count <50 cells/mm³ who are initiating ART. Participating sites must have a regional TB incidence (i.e., the TB incidence within the site’s expected catchment area) of more than 100 cases/100,000 population per year, a national ART program, and documented high mortality rates among HIV-infected individuals (i.e., at least 5% overall at 6 months post ART initiation). Sites whose regional TB incidence or mortality rates approach but do not meet the requirements stated above may be approved on a case-by-case basis by the study team, following a review of all relevant information. Participants with probable or confirmed TB at screening will be excluded.</p>\n <p style=\"margin-left: 40px;\">\n <u>RANDOMIZATION</u>    1:1 to empiric or local standard of care TB treatment</p>\n <p style=\"margin-left: 40px;\">\n Participants will be randomized to initiate TB treatment either at entry (Arm A, empiric) or when indicated according to local practice and the discretion of the site investigator (Arm B, local standard of care).</p>\n <p style=\"margin-left: 40px;\">\n <u>STRATIFICATION</u>     Randomization will be stratified according to CD4+ cell count (<25 vs. ≥25 cells/mm³) and presence of poor prognostic factors (i.e., absence of all vs. presence of at least one of the following: reportable hospitalization [see section 6.3.5) within the past 30 days, body mass index [BMI] <18.5, or anemia [hemoglobin <8 g/dl]).</p>\n <p>\n <u>REGIMEN</u>      Section 5.1 provides detailed information about treatment options and their provision.</p>\n <p>\n                         All participants will receive efavirenz-(EFV) based ART beginning at study entry.  </p>\n <p>\n The TB treatment described below must be obtained by the sites as described in section 5.3.1.</p>\n <p>\n Pyridoxine will be provided by the sites to all participants while they are receiving isoniazid (INH) to prevent emergence of neuropathy associated with INH use. All participants will be provided <em>Pneumocystis jiroveci </em>pneumonia (PCP) prophylaxis by the sites according to local guidelines.</p>\n <p>\n Regimens by arm:</p>\n <p style=\"margin-left: 40px;\">\n <u>Arm A (empiric)</u></p>\n <p>\n EFV-based ART (see section 5.1.1)</p>\n <p>\n Plus  </p>\n <p>\n Full TB treatment course, defined as:</p>\n <ul>\n <li>\n <p>\n rifampin/isoniazid/ethambutol/pyrazinamide (RIF/INH/EMB/PZA) for 8 weeks,</p>\n </li>\n </ul>\n <p>\n followed by</p>\n <ul>\n <li>\n <p>\n RIF/INH only for 16 weeks</p>\n </li>\n </ul>\n <p>\n <u>Arm B Regimen (standard of care)</u></p>\n <p>\n EFV-based ART alone</p>\n <p>\n If TB treatment is subsequently indicated for participants in either arm according to local standard practice and/or discretion of site investigator, then the TB treatment described above should be initiated.</p>\n <p style=\"margin-left: 40px;\">\n  </p>\n</div>\n<p>\n  </p>\n
      • study_title<p>\n A5274/REMEMBER "Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens"</p>\n
      • laymans_summary<p>\n In this randomized, open-label strategy trial, participants from RLS who present with advanced HIV disease and will be initiating ART but are without evidence of probable or confirmed TB according to criteria in the current ACTG diagnosis appendix (which will be identified on the case report form [CRF]) will be randomized 1:1 to one of two strategy arms: empiric TB treatment (public health approach, Arm A) or local standard of care (individualized TB treatment approach, Arm B) at study entry. At the 48 week visit, participants will transition to a 48-week follow-up period of non-study-provided treatment and care, with total study duration being 96 weeks.</p>\n<p>\n The primary endpoint is survival status at 24 weeks post randomization. AIDS progression, virologic and immunologic response, development of plasma HIV drug resistance, resistance to TB drugs, safety and tolerability of ART and TB drugs, and adherence to ART and TB drugs will also be evaluated as will the relative cost-effectiveness of the two strategies.</p>\n
      • short_titleREMEMBER
      • protocol_noECCT/11/07/02
      • version_noVersion 1.0
      • date_of_protocol29-10-2010
      • study_drugRifampin/Isoniazid/Pyrazinamide/Ethambutol
      • disease_conditionEmpiric treatment of TB
      • 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_nameFDC RHZE, FDC RH
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaksudoi@hotmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantAllan K Sudoi
      • declaration_date131-05-2013
      • declaration_principal_investigatorAbraham M Siika, MBChB, MMed, Msc - Site Principal Investigator
      • declaration_date231-05-2013
      • placebo_presentNo
      • study_objectives<h2>\n Primary Objective</h2>\n<p>\n  </p>\n<p style=\"margin-left:36.0pt;\">\n To compare survival probabilities between the two study arms 24 weeks after randomization.</p>\n<p>\n  </p>\n<h2>\n  Secondary Objectives</h2>\n<p>\n  </p>\n<ol>\n <li>\n To compare the time to death between the two arms.</li>\n <li>\n To compare the time to AIDS progression or death between the two arms.</li>\n <li>\n To compare the survival without AIDS progression 24 and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare Probabilities of plasma HIV-1 RNA levels of <400 copies/mL at 4, 24, and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare rates of safety and tolerability (including Grades 3 and 4 events, immune reconstitution inflammatory syndrome [IRIS] events, ART and TB treatment changes, and rates/causes of reportable hospitalization) of ART and TB treatment 24 and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare changes in CD4+ cell counts 4, 24, and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare cause of death, including TB-specific mortality, between the two arms through 96 weeks.</li>\n <li>\n To compare ART adherence by self-report 4, 24, and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare TB incidence between the two arms from randomization through week 48 and week 96.</li>\n <li>\n To explore TB incidence by geographic region and by arm.</li>\n <li>\n To compare adherence to TB treatment between the two arms while participants are receiving TB treatment.</li>\n <li>\n To compare resistance to TB drugs at time of incident TB between the two arms.</li>\n <li>\n To compare cost-effectiveness of the treatment strategies between the two arms.</li>\n <li>\n To compare quality of life between the two arms.</li>\n <li>\n To compare cost effectiveness of intervention by intensity of TB evaluation practices.</li>\n <li>\n To evaluate the evolution of plasma HIV-1 drug resistance through week 48.</li>\n <li>\n To evaluate issues related to dietary intake and food insecurity and their relation to early mortality.</li>\n <li>\n To assess the relationship between levels of bacterial and/or fungal DNA in plasma at study entry and during ART treatment and survival at 24 weeks.</li>\n</ol>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n
      • principal_inclusion_criteria<p>\n Contained in section 4.1 of the protocol</p>\n<h2>\n 4.1       Inclusion Criteria</h2>\n<p style=\"margin-left: 80px;\">\n 4.1.1    HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 80px;\">\n The WHO and the U.S. Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 80px;\">\n NOTE: The term “licensed” refers to a kit that has been certified or licensed by an oversight body within the country in which it is used and has been validated internally.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.2    Willingness to start efavirenz-based ART as soon as possible and within no more than 3 days following randomization.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.3    CD4+ cell count <50 cells/mm³ obtained within 45 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.4    Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and total bilirubin ≤ 2.5 X ULN within 30 days prior to study entry.</p>\n<ol>\n <li value=\"NaN\">\n <p>\n Creatinine clearance ≥30 mL/min either measured or estimated* using values obtained within 30 days prior to study entry.  </p>\n </li>\n</ol>\n<p style=\"margin-left: 80px;\">\n *If not measured, then creatinine clearance must be estimated using the Cockcroft-Gault equation which is available at <a href=\"https://www.fstrf.org/\">https://www.fstrf.org</a></p>\n<p style=\"margin-left: 80px;\">\n under Calculators/Calculator Utilities.</p>\n<ol start=\"2\">\n <li>\n <p>\n Results from a hepatitis B surface antigen test performed within 30 days prior to study entry. (Section 6.3.12 contains information about enrollment of and treatment selection for co-infected participants.)</p>\n </li>\n <li value=\"NaN\">\n <p>\n Agreement not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</p>\n </li>\n</ol>\n<p style=\"margin-left: 80px;\">\n 4.1.8    Female candidates of reproductive potential must have a negative serum or urine (15-25 mIU/mL) pregnancy test result within 7 days prior to study entry.</p>\n<p style=\"margin-left: 80px;\">\n “Female candidates of reproductive potential” is defined as women who have reached menarche or who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) or have not undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy or salpingectomy).</p>\n<p style=\"margin-left: 80px;\">\n 4.1.9    Female candidates of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception while on study: a barrier method of contraception (condoms or cervical cap) together with another reliable form of contraceptive (condoms with a spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, or hormone-based contraceptive) while receiving EFV, RIF, or other rifamycin, and for 6 weeks after stopping these drugs.</p>\n<ul>\n <li>\n <p>\n Female candidates who are not of reproductive potential, as defined above, or whose male partner(s) has undergone successful vasectomy with documented azoospermia or has documented azoospermia for any other reason, are eligible without requiring the use of contraceptives. Candidate-reported history is acceptable documentation of menopause, hysterectomy, or bilateral oophorectomy or salpingectomy.</p>\n </li>\n</ul>\n<p style=\"margin-left: 120px;\">\n NOTE: Written or oral documentation confirming lack of reproductive potential communicated by clinician or clinician’s staff of one of the following <strong>is</strong> required for participants receiving EFV: physician report/letter, discharge summary, FSH (follicle-stimulating hormone) measurement elevated into the menopausal range as established by the reporting laboratory. In addition, the participant’s own statement regarding her or her partner’s lack of reproductive potential must be recorded in the source documentation.</p>\n<p style=\"margin-left: 120px;\">\n If a female candidate reports infertility, as defined above, but does not have either written or oral documentation from a clinic or physician, or <strong>she </strong>states that her partner has had a vasectomy but documentation is unavailable, she must agree to use at least one barrier method of contraception with a possible second method to be required at the discretion of the site investigator.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.10  Karnofsky performance score ³30 at time of study entry.</p>\n<p style=\"margin-left: 80px;\">\n       </p>\n<p style=\"margin-left: 120px;\">\n            NOTE: As always, using best clinical judgment and all information available to them, site investigators retain the responsibility for determining whether patients who meet this criterion are appropriate candidates for this study.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.11  Males and females age ³13 years.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.12  Ability to swallow medications.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.13  Ability and willingness of participant or legal guardian/representative to provide informed consent.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.14 Intention to remain in the same general geographic region for the duration of study participation (i.e., participant will be able to obtain transportation to the site throughout the study).</p>\n
      • principal_exclusion_criteria<p>\n Found in section 4.2 of the protocol</p>\n<h2>\n 4.2       Exclusion Criteria</h2>\n<ol>\n <li value=\"NaN\">\n Within 30 days prior to study entry and following completion of study-specific screening algorithm (see section 4.3.6), presence of any confirmed or probable TB based on criteria listed in the current ACTG diagnosis appendix, which is identified on the CRF.</li>\n <li value=\"NaN\">\n Use of single-dose NVP for prevention of mother-to-child transmission (pMTCT) within 24 months prior to study entry.</li>\n</ol>\n<p style=\"margin-left:108.0pt;\">\n NOTE: Combination antiretrovirals (ARVs) taken for any length of time during pregnancy for pMTCT is not exclusionary.</p>\n<ol start=\"3\">\n <li>\n Use of prohibited medications (see list in A5274/REMEMBER MOPS, section 3.2.1) within 30 days prior to study entry.</li>\n <li value=\"NaN\">\n Known allergy/sensitivity or any hypersensitivity to components of study-required ART or TB treatment.</li>\n <li value=\"NaN\">\n Current receipt of treatment for active TB or receipt of >14 days cumulative treatment for active TB within 96 weeks prior to study entry.</li>\n <li value=\"NaN\">\n Receipt of >30 days cumulative of INH prophylaxis within 48 weeks prior to study entry.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n 4.2.7    Receipt at any time prior to study entry of >7 days cumulative treatment with any ARV or combination of ARVs (except for ARVs taken for any length of time during pregnancy for pMTCT, or ARVs taken for occupational exposure).</p>\n<p style=\"margin-left:72.0pt;\">\n 4.2.8    Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.</p>\n<ol start=\"7\">\n <li>\n Current Grade ≥2 neuropathy.</li>\n <li value=\"NaN\">\n History of multi-drug-resistant (MDR) TB.</li>\n <li value=\"NaN\">\n Within 12 weeks prior to entry, exposure to a household member or co-worker with known MDR TB.</li>\n</ol>\n
      • primary_end_points<p style=\"margin-left:36.0pt;\">\n Survival status at 24 weeks post randomization</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Abraham M. Siika MBChB, MMed, MS- Site Leader/ Principal Investigator</p>\n<p>\n  David Lagat - MBChB, MMed- Investigator</p>\n<p>\n Charles Kwobah, MBChB- Medical Officer</p>\n<p>\n Mercy Karoney  MBChB- Medical Officer</p>\n<p>\n Simon Wachira Njuguna, B Pharm, MPSK - Pharmacist of Record</p>\n<p>\n Kipruto Kirwa, BSc, MPH, PhD- Quality Manager</p>\n<p>\n Priscilla Cheruiyot, BScN, MPH- Site Coordinator</p>\n<p>\n Martha Mokaya, BSc, MBA- Data Manager</p>\n<p>\n Wilson Lokitala Ekiru, BSc IT- Assistant Data Manager</p>\n<p>\n Agnes M. Nzioka, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Betty Meli, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Michael Tanui, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Julie Choge -  Recruitment Officer</p>\n<p>\n Amina Msuo Shali-  Recruitment Officer</p>\n<p>\n Dorothy Mwimali -  Recruitment Officer</p>\n<p>\n Cecilia Chebet, Dip Counselling - Recruitment Officer</p>\n<p>\n Beatrice Jakait, B Pharm- Back-up Pharmacist</p>\n<p>\n Zipporah Sambili, Dip Pharm- Back-up Pharmaceutical Technologist</p>\n<p>\n Chris Sande, KHRCN- Study Nurse</p>\n
      • other_details_explanation<table align=\"center\" cellpadding=\"0\" cellspacing=\"0\" hspace=\"0\" vspace=\"0\">\n <tbody>\n <tr>\n <td align=\"left\">\n <p style=\"margin-left:7.2pt;\">\n This study is being conducted in resource limited settings. Participating sites must have a regional TB incidence (i.e., the TB incidence within the site’s expected catchment area) of more than 100 cases/100,000 population per year, a national ART program, and documented high mortality rates among HIV-infected individuals (i.e., at least 5% overall at 6 months post ART initiation).</p>\n </td>\n </tr>\n </tbody>\n</table>\n<div style=\"clear:both;\">\n  </div>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n  Moi Teaching and Referral Hospital/Moi University Institutional Research and Ethics Committee (IREC). Continuing Approval granted on 14 June 2012 for Eldoret site only.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration96 weeks. Participants will transition to locally provided care and treatment at week 48.
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorEFV-based ART (see sectio
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states11
      • number_of_sites2
      • multi_country_listKenya, India, Peru, South Africa, Malawi, Haiti, Brazil, Uganda, Zambia, Tanzania, Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_siteInformation not immediately available
      • total_participants_worldwide836
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailamsiika@africaonline.co.ke
      • organisations_transferred_No
      • number_participants100 participants at the Eldoret site
      • notification
      • approval_date29-10-2010
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted10-08-2020
      • 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)
      • modified2020-08-10 11:42:35
      • created2013-05-22 16:28:51
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id85
        • application_id137
        • given_nameAbraham
        • middle_nameMosigisi
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP O Box, 4606-30100, Eldoret
        • telephone0721280785
        • emailamsiika@africaonline.co.ke
        • created2013-05-22 17:01:26
        • modified2020-08-10 11:42:35
    • SiteDetail(array)
      • 0(array)
        • id106
        • application_id137
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressAMPATH at MTRH, Nandi Road, Eldoret
        • contact_details+254 53 2060850
        • contact_personAllan Sudoi
        • site_capacity(null)
        • misc(null)
        • created2013-05-22 17:01:26
        • modified2020-08-10 11:42:35
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 1(array)
        • id108
        • application_id137
        • county_id35
        • site_nameWalter Reed Project
        • physical_addressKericho District Hospital
        • contact_details0713603225
        • contact_personHellen Ngeno
        • site_capacity(null)
        • misc(null)
        • created2013-05-31 09:42:50
        • modified2020-08-10 11:42:35
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id66
        • application_id137
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_personMina C. Hosseinipour, M.D., M.P.H
        • addressKamuza Central Hospital, Tidziwe Centre, 100 Mzimba Road, Private Bag A-104, Lilongwe, MALAWI
        • telephone_number265 1 758 938
        • fax_number265 1 755 954
        • cell_number265 1 758 938
        • email_addressminach@med.unc.edu
        • created2013-05-22 17:01:26
        • modified2020-08-10 11:42:35
  • 4(array)
    • Application(array)
      • id150
      • user_id80
      • trial_status_id7
      • abstract_of_study<div>\n PROTOCOL SUMMARY </div>\n<div>\n  </div>\n<div>\n Phase: II</div>\n<div>\n  </div>\n<div>\n Population: 234 women who are sexually active (>4 episodes of heterosexual intercourse during the past month), HIV-seronegative, 18 to 45 years old, with bacterial vaginosis (BV) and/or vulvovaginal candidiasis (VVC) and/or <em>Trichomonas vaginalis</em> detected by laboratory testing at a screening visit</div>\n<div>\n  </div>\n<div>\n Number of Sites: Four (3 in Kenya and 1 in the U.S.)</div>\n<div>\n  </div>\n<div>\n Study Duration: 24 months for accrual and follow-up </div>\n<div>\n  </div>\n<div>\n Subject Participation Duration: 12 months total (Enrollment to End of Study Evaluation) </div>\n<div>\n  </div>\n<div>\n Description of Agent or Intervention: Intravaginal metronidazole 750 mg plus miconazole 200 mg (coformulated suppositories) versus matching placebo </div>\n<div>\n suppositories nightly for five consecutive nights each month </div>\n<div>\n  </div>\n<div>\n Indication: Treatment for bacterial vaginosis and/or vulvovaginal candidiasis and/or <em>Trichomonas vaginalis </em>infection and/or mixed infections with two or more of these conditions </div>\n<div>\n  </div>\n<div>\n Objectives:</div>\n<div>\n Primary - To evaluate the effect of monthly periodic presumptive treatment (PPT) using topical metronidazole 750 mg with miconazole 200 mg intravaginal suppositories versus matching placebo nightly for five nights each month for reducing the rates of BV by Gram stain (Nugent’s criteria) and VVC (detection on vaginal saline/KOH wet mount plus positive culture on Sabouraud’s agar) in a randomized, double-blind, placebocontrolled trial in sexually active, HIV-seronegative women. The two primary endpoints, BV and VVC, will be analyzed separately. </div>\n<div>\n  </div>\n<div>\n <div>\n Secondary - To evaluate the effect of monthly PPT using topical metronidazole 750 mg with miconazole 200 mg intravaginal suppositories versus matching placebo nightly for five nights each month for reducing the overall rate of vaginal infections (combined endpoint including BV by Gram stain [Nugent’s criteria], VVC [vaginal saline/KOH wet mount plus positive culture on Sabouraud’s agar] and Trichomonas vaginalis infection [nucleic acid amplification based detection]) in a randomized, double-blind, placebo-controlled trial in sexually active, HIV-seronegative women. To evaluate the effect of monthly PPT using topical metronidazole 750 mg with miconazole 200 mg intravaginal suppositories versus matching placebo nightly for five nights each month for reducing the rate of BV by clinical criteria (Amsel’s criteria) in a randomized, double-blind, placebocontrolled trial in sexually active, HIV-seronegative women. </div>\n <div>\n  </div>\n <div>\n Description of Study Design: </div>\n <div>\n The proposed study is a randomized, double-blind, placebocontrolled, two arm clinical trial (N=117 in each arm). </div>\n</div>\n<p>\n  </p>\n
      • study_title<div>\n A Double-blind, Randomized Trial of Monthly Treatment with Metronidazole and Miconazole Co-formulated Suppositories versus Placebo for Preventing Vaginal Infections in HIVSeronegative Women (DMID Protocol Number: 09-0070)</div>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/11/04/01
      • version_no1.0
      • date_of_protocol29-07-2010
      • study_drugIntravaginal metronidazole 750 mg plus miconazole 200 mg (coformulated suppositories)
      • disease_conditionTreatment for bacterial vaginosis and/or vulvovaginal candidiasis and/or Trichomonas vaginalis infection and/or mixed infections
      • 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_nameIntravaginal metronidazole 750 mg plus miconazole 200 mg (coformulated suppositories)
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmclell@uw.edu
      • 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_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_applicantScott McClelland
      • declaration_date128-06-2013
      • declaration_principal_investigatorScott McClelland
      • declaration_date228-06-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<div>\n • Informed consent obtained and informed consent form (ICF) signed </div>\n<div>\n • Female, aged 18-45 years </div>\n<div>\n • Sexually active with >4 episodes of sex with a male partner during the past month </div>\n<div>\n • HIV-seronegative on both HIV tests in parallel screening </div>\n<div>\n • Presence of BV and/or VVC and/or T. vaginalis infection at screening: </div>\n<ul>\n <li>\n BV: Microscopic criteria (Nugent’s score <u>></u>7) </li>\n <li>\n VVC: Fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud’s agar</li>\n <li>\n <em>T. vaginalis i</em>nfection: Identification of motile trichomonads on vaginal saline wet preparation </li>\n</ul>\n<div>\n • Able and willing to comply with study visit schedule and procedures during the 12-month period of follow-up </div>\n<div>\n • Able and willing to abstain from sex or to use non-latex condoms (provided) for 24 hours following insertion of each vaginal suppository </div>\n<div>\n • Willing to abstain from alcohol during, and for 48 hours after, treatment </div>\n<div>\n • Plan to remain in study area for the next year </div>\n<div>\n • Agree to not participate in other research studies involving drugs, medical devices, or vaginal products for the duration of study</div>\n
      • principal_exclusion_criteria<div>\n • Currently pregnant (positive urine β-hCG) or planning to conceive during the next 12 months (by self-report) </div>\n<div>\n • Currently breastfeeding </div>\n<div>\n • Within first 3 months post-partum </div>\n<div>\n • Current menstruation – women who are currently menstruating may be enrolled following the completion of menses </div>\n<div>\n • History of 4 or more episodes of treatment for any vaginal infection in the past 12 months. This would be a cumulative total, including any treatment for BV and/or VVC and/or TV and/or syndromic. </div>\n<div>\n • History of medical condition that would contraindicate use of the study product: </div>\n<ul>\n <li>\n Porphyria </li>\n <li>\n Epilepsy </li>\n <li>\n Serious liver disease or signs and symptoms consistent with serious liver disease including jaundice, ascites, esophageal varices, encephalopathy, and bleeding disorders </li>\n <li>\n Renal failure </li>\n</ul>\n<div>\n • History of adverse reaction to the study medications (intravaginal metronidazole or miconazole) </div>\n<div>\n • Current use of medication that may interact with the study drug (due to vaginal absorption of study drug): </div>\n<ul>\n <li>\n Warfarin </li>\n <li>\n Phenytoin </li>\n <li>\n Phenobarbital </li>\n <li>\n Disulfiram </li>\n <li>\n Cimetidine </li>\n <li>\n Lithium </li>\n <li>\n Astemizole </li>\n <li>\n Terfenadine </li>\n</ul>\n<div>\n • Current use of oral or intravaginal antifungal medication </div>\n<div>\n • Current use of oral or intravaginal metronidazole, tinidazole, or clindamycin </div>\n<div>\n • Current use of latex diaphragm </div>\n<div>\n • As determined by the investigator, a medical condition or situation exists such that study participation would not be advisable. </div>\n
      • primary_end_points<p>\n This study has two primary endpoints: </p>\n<ol>\n <li>\n BV by Gram stain (Nugent’s criteria)</li>\n <li>\n VVC (detection on vaginal saline/KOH wet mount plus positive culture on Sabouraud’s agar) </li>\n</ol>\n<p>\n The two primary endpoints, BV and VVC, will be analyzed separately.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:640px;\" width=\"480\">\n <tbody>\n <tr>\n <td style=\"width:241px;\">\n <p>\n DMID Protocol Number</p>\n </td>\n <td style=\"width:399px;\">\n <p>\n 09-0070</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Protocol Title</p>\n </td>\n <td style=\"width:399px;\">\n <p>\n A double-blind randomized trial of monthly treatment with topical metronidazole and miconazole and co-formulated suppositories versus placebo for preventing vaginal infection in HIV-seronegative women</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Proposed site:</p>\n </td>\n <td style=\"width:399px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n Site-Investigator’s name</p>\n </td>\n <td style=\"width:399px;\">\n <p>\n Prof. Omu Anzala, MB,ChB, PhD</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n Name of institution/facility</p>\n </td>\n <td style=\"width:399px;\">\n <p>\n Kenya AIDS Vaccine Initiative (KAVI)</p>\n <p>\n Department of Medical Microbiology</p>\n <p>\n University of Nairobi</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n City, state, country</p>\n </td>\n <td style=\"width:399px;\">\n <p>\n Nairobi, Kenya</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:23px;\">\n <p style=\"margin-left:.25in;\">\n Email address</p>\n </td>\n <td style=\"width:399px;height:23px;\">\n <p>\n <a href=\"mailto:oanzala@kaviuon.org\">oanzala@kaviuon.org</a></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:23px;\">\n <p style=\"margin-left:.25in;\">\n Brief description of site/facility</p>\n </td>\n <td style=\"width:399px;height:23px;\">\n <p>\n KAVI was established in 1999 as a research unit at the Department of Medical Microbiology, College of Health Sciences, University of Nairobi. It comprises of a fully equipped clinic, Pharmacy, community team, IT/Data, advanced research and safety laboratories, administration and finance department.  The research activities are sponsored by International AIDS Vaccine Initiative (IAVI).  KAVI has two sites namely; KAVI-KNH which is mainly a Phase I site where the four clinical trials have been undertaken since 2001and KAVI-Kangemi which is a clinical site devoted to conducting Phase IIB/III vaccine trials (Efficacy trials) and feasibility studies.</p>\n <p>\n  </p>\n <p>\n The KAVI research team is appropriately trained with majority of members having at least 5 years experience in clinical research.         </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Site-Investigator’s experience:</p>\n </td>\n <td style=\"width:399px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:35px;\">\n <p style=\"margin-left:.25in;\">\n With the protocol topic</p>\n </td>\n <td style=\"width:399px;height:35px;\">\n <p>\n Prof. Anzala managed the KAVI laboratory during the conduct of five HIV vaccine clinical trials; during these studies there was recruitment of high-risk individuals and screening for STIs / genital infections. Additionally, Prof. Anzala previously worked in the nearby Majengo Clinic for over five years, where he gained extensive experience in HIV/STI cohort research.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:35px;\">\n <p style=\"margin-left:.25in;\">\n Conducting clinical trials</p>\n </td>\n <td style=\"width:399px;height:35px;\">\n <p>\n Prof. Anzala has been a principal investigator in three clinical studies and is currently the Program Director of KAVI, where he is in charge of three principal investigators of different studies. Before that, he was the Project Director of KAVI for five years.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Description of clinic facilities and capabilities:</p>\n <p>\n  </p>\n </td>\n <td style=\"width:399px;\">\n <p>\n  </p>\n <p>\n The clinic has an outdoor waiting area, several exam and counseling rooms, an onsite lab, and area for data management and secure data storage.</p>\n <p>\n All the core personnel have experience in all stages of protocol development and implementation. Staff are trained in the ICH-GCP, GCLP, GPP requirements as well as the country specific regulatory requirements. The staff have experience in the US-CFR requirements that govern clinical trials and have all undergone the human subject protection training.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Description of lab facilities and capabilities:</p>\n <p>\n  </p>\n </td>\n <td style=\"width:399px;\">\n <p>\n The onsite laboratory can support some routine tests, such as vaginal wet mounts and pregnancy testing. Additional samples are collected and transported daily to a central, well-equipped laboratory at the College of Health Sciences.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Summary of Study Site feasibility:</p>\n </td>\n <td style=\"width:399px;\">\n <p>\n KAVI staff have worked on site for the last 10 years.  They have the experience needed in conducting clinical trials.  KAVI has mapped the site and is able to utilize the experienced community mobilizers in identifying site participants required for these trials.  In addition, KAVI has sufficient infrastructure required to conduct the study.</p>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:643px;\" width=\"482\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width:643px;height:19px;\">\n <p>\n <strong>Key Personnel at Proposed Study Site:</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:196px;height:19px;\">\n <p>\n <strong>Title</strong></p>\n </td>\n <td style=\"width:233px;height:19px;\">\n <p>\n <strong>Name</strong></p>\n </td>\n <td style=\"width:214px;height:19px;\">\n <p>\n <strong>Qualification</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:196px;height:19px;\">\n <p>\n Site-Investigator</p>\n </td>\n <td style=\"width:233px;height:19px;\">\n <p>\n Prof. Omu Anzala, MBChB, PhD</p>\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:214px;height:19px;\">\n <p>\n See above qualifications</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:196px;height:19px;\">\n <p>\n Research clinician(s)</p>\n </td>\n <td style=\"width:233px;height:19px;\">\n <p>\n Dr. Florence Mutua, MBChB, MSc</p>\n <p>\n  </p>\n <p>\n Dr. Rhoda Mutia, MBChB</p>\n <p>\n  </p>\n </td>\n <td style=\"width:214px;height:19px;\">\n <p>\n The research clinicians are very experienced in women’s health and clinical research. They are well trained in screening, enrolling and retaining subjects for research studies.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:196px;height:20px;\">\n <p>\n Nurse Counselors</p>\n </td>\n <td style=\"width:233px;height:20px;\">\n <p>\n Ms. Janet Muriithi</p>\n <p>\n  </p>\n <p>\n Ms. Jane Odada</p>\n <p>\n  </p>\n </td>\n <td style=\"width:214px;height:20px;\">\n <p>\n Kenya Registered Nurses (KRN) with additional training in counseling. The research nurses are very experienced in women’s health and clinical research.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:196px;height:20px;\">\n <p>\n Community Mobilizers</p>\n </td>\n <td style=\"width:233px;height:20px;\">\n <p>\n Ms. Rose Mahira</p>\n <p>\n  </p>\n <p>\n Joseph Gachira</p>\n </td>\n <td style=\"width:214px;height:20px;\">\n <p>\n KRN with training in community outreach</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:196px;height:20px;\">\n <p>\n Laboratory Technologists</p>\n </td>\n <td style=\"width:233px;height:20px;\">\n <p>\n Mrs. Kabiru</p>\n <p>\n  </p>\n <p>\n Ms. Susan Odera, Msc</p>\n </td>\n <td style=\"width:214px;height:20px;\">\n <p>\n The laboratory staff have experience with the laboratory procedures required for this study.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:196px;height:20px;\">\n <p>\n Secretary</p>\n </td>\n <td style=\"width:233px;height:20px;\">\n <p>\n Ms. Christine Obare</p>\n <p>\n  </p>\n </td>\n <td style=\"width:214px;height:20px;\">\n <p>\n Diploma in Secretarial</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:196px;height:20px;\">\n <p>\n Driver</p>\n </td>\n <td style=\"width:233px;height:20px;\">\n <p>\n Mr. Gregory Akoi</p>\n </td>\n <td style=\"width:214px;height:20px;\">\n <p>\n Driving License Class A, B, C & E</p>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:241px;\">\n <p>\n DMID Protocol Number</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n 09-0070</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Protocol Title</p>\n </td>\n <td style=\"width:349px;\">\n <p align=\"left\">\n A double-blind randomized trial of monthly treatment with topical metronidazole and miconazole and co-formulated suppositories versus placebo for preventing vaginal infection in HIV-seronegative women</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Proposed site:</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n Korogocho sex workers clinic Nairobi, Kenya</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n Site-Investigator’s name</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n Dr. Joshua Kimani</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n Name of institution/facility</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n Kenya AIDS Control Project,</p>\n <p>\n College of Health Sciences</p>\n <p>\n University of Nairobi</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n City, state, country</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n Nairobi, Kenya</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:23px;\">\n <p style=\"margin-left:.25in;\">\n Email address</p>\n </td>\n <td style=\"width:349px;height:23px;\">\n <p>\n jkimani@csrtkenya.org</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:23px;\">\n <p style=\"margin-left:.25in;\">\n Brief description of site/facility</p>\n </td>\n <td style=\"width:349px;height:23px;\">\n <p>\n The Korogocho sex workers clinic is housed within a Nairobi City Council owned health clinic. The facility provides primary health care services to about 300,000 Korogocho slum residents and other members of the general population from the surrounding areas.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Site-Investigator’s experience:</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n With the protocol topic</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n The site investigator has been involved with targeted interventions for female sex workers in Kenya for the past 15 years. He has also successfully completed three phase III clinical trials. One such trial involved monthly prophylaxis with Azithromycin or placebo to sex workers in Kibera slums an attempt to reduce incident classical STDS and indirectly HIV sero-conversion.  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:35px;\">\n <p style=\"margin-left:.25in;\">\n Conducting clinical trials</p>\n </td>\n <td style=\"width:349px;height:35px;\">\n <p>\n The site investigator is GCP trained and formerly a medical director for phase II and III Malaria clinical trials managed by FHI in several countries in Africa.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Description of clinic facilities and capabilities:</p>\n <p>\n  </p>\n </td>\n <td style=\"width:349px;\">\n <p>\n The facility has ten rooms and three of them are allocated /dedicated to the ongoing ARV/Care and prevention programs targeting female sex workers from the area.</p>\n <p>\n  </p>\n <p>\n The site personnel have the required training and skills to perform all the study specific assessments as per the study protocol.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Description of lab facilities and capabilities:</p>\n <p>\n  </p>\n </td>\n <td style=\"width:349px;\">\n <p>\n The site laboratory can only support routine tests.  For more advanced laboratory testing, samples routinely collected from the sex workers are transported daily to a central, well-equipped laboratory at the College of Health Sciences. This laboratory built with support from the Canadian Foundation of Innovation (CFI) supports all the diagnostics tests on samples collected from the sex workers programs and results provided to the clinicians in a timely fashion to aid care provision. Hence, the Korogocho health center will only be used as a recruitment, sample collection and follow-up site for the clinical trial.</p>\n <p>\n  </p>\n <p>\n The central laboratory personnel have the required training and skills to perform all the lab tests as per the study protocol.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Summary of Study Site feasibility:</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n The Korogocho clinic is well placed to execute the study. We have access to a large population of appropriate /suitable clients with incident BV and VVC. The central labs at the College of Health Sciences, University of Nairobi have superb facilities and skilled manpower to support the trial.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width:590px;\">\n <p>\n Key Personnel at Proposed Study Site:</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Title</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Name</p>\n </td>\n <td style=\"width:196px;\">\n <p>\n Qualification</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Site-Investigator</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Joshua Kimani, MBChB, MPH</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n See above qualifications</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Study Coordinator/Manager</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Jessie Kwatampora, MBChB</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Research clinician(s)</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n 2 Nurses with either a BSC- Nursing or KRN</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Mobilizer</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n BA Social work</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:241px;\">\n <p>\n DMID Protocol Number</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n 09-0070</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Protocol Title</p>\n </td>\n <td style=\"width:349px;\">\n <p align=\"left\">\n A double-blind randomized trial of monthly treatment with topical metronidazole and miconazole and co-formulated suppositories versus placebo for preventing vaginal infection in HIV-seronegative women</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Proposed site:</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n Site-Investigator’s name</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n R. Scott McClelland, MD, MPH</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n Name of institution/facility</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n Mombasa HIV/STD Research Site,</p>\n <p>\n Ganjoni Municipal Clinic</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p style=\"margin-left:.25in;\">\n City, state, country</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n Mombasa, Kenya</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:23px;\">\n <p style=\"margin-left:.25in;\">\n Email address</p>\n </td>\n <td style=\"width:349px;height:23px;\">\n <p>\n mcclell@u.washington.edu</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:23px;\">\n <p style=\"margin-left:.25in;\">\n Brief description of site/facility</p>\n </td>\n <td style=\"width:349px;height:23px;\">\n <p>\n The Mombasa HIV/STD Research Site, established in 1993, is a collaborative effort of the University of Nairobi, the University of Washington (UW), the Kenya Medical Research Institute (KEMRI), the Municipality of Mombasa, the Ministry of Health, Coast Provincial General Hospital (CPGH), The Fred Hutchinson Cancer Research Center (FHCRC) and the US President’s Emergency Program for AIDS Relief. </p>\n <p>\n  </p>\n <p>\n Since 1993, the site has provided VCT to ~8,000 and care to >2,600 at-risk and HIV-positive women enrolled in an ongoing prospective cohort study.  In addition, the site has trained >50 Kenyan researchers and published >100 manuscripts presenting the findings of HIV prevention, treatment, and pathogenesis studies.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Site-Investigator’s experience:</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:35px;\">\n <p style=\"margin-left:.25in;\">\n With the protocol topic</p>\n </td>\n <td style=\"width:349px;height:35px;\">\n <p>\n Dr. McClelland is the author of the protocol and has been engaged in research on STIs in women for over 10 years. He is an expert in vaginal infections, women’s health, and HIV/STI epidemiology in Africa.  He has published over 50 peer-reviewed research articles including numerous publications on the epidemiology, prevention, and treatment of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;height:387px;\">\n <p style=\"margin-left:.25in;\">\n Conducting clinical trials</p>\n </td>\n <td style=\"width:349px;height:387px;\">\n <p>\n Dr. McClelland has conducted several clinical trials. Most recently, he served as principal investigator for a randomized double-blind, placebo-controlled trial to evaluate the efficacy of monthly oral PPT for reducing the rates of vaginal infections among HIV-seronegative female sex workers (FSW) from Mombasa, Kenya. From May 2003 to November 2005, 378 HIV-seronegative women were screened, of whom 310 (82%) were enrolled and randomly assigned to receive either the intervention regimen (metronidazole 2g plus fluconazole 150mg) or matching placebos as monthly directly observed therapy (DOT).</p>\n <p>\n  </p>\n <p>\n In addition, Dr. McClelland led a randomized, double-blind, placebo-controlled trial that assessed the effect of micronutrient supplementation on cervical and vaginal HIV-1 shedding. From September 1998 to June 2000, 400 women were enrolled in the trial.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Description of clinic facilities and capabilities:</p>\n <p>\n  </p>\n </td>\n <td style=\"width:349px;\">\n <p>\n The clinic has two fully equipped research examination rooms and four interview/counseling rooms. A separate climate controlled room is available for the storage of pharmaceuticals. The clinic also includes indoor and outdoor waiting areas.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Description of lab facilities and capabilities:</p>\n <p>\n  </p>\n </td>\n <td style=\"width:349px;\">\n <p>\n The Mombasa STD/HIV Research Site has a clinical laboratory with the ability to perform HIV-1 ELISA, HSV-2 ELISA, cultures for gonorrhea, trichomoniasis and lactobacilli, GenProbe APTIMA Combo2 (CT/GC) detection, microscopy, cryopreservation and storage of samples.</p>\n <p>\n  </p>\n <p>\n All of the laboratory tests specified in the current proposal can be performed at our laboratory.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:241px;\">\n <p>\n Summary of Study Site feasibility:</p>\n </td>\n <td style=\"width:349px;\">\n <p>\n The research staff at the Mombasa STD/HIV Research Site has conducted an ongoing open cohort study of women in this community for 16 years.  The staff is highly experienced in women’s health research and clinical care.  Dr. McClelland and his research team recently completed a similar trial that successfully met it targets for high rates of participant recruitment and retention. </p>\n <p>\n  </p>\n <p>\n We feel that Mombasa STD/HIV Research Site has the physical infrastructure, human resource capacity, and access to the appropriate target population necessary to successfully complete the current trial.  In addition, our laboratory is uniquely suited to provide support not only to the Mombasa site, but for other trial sites in Africa as well. Specifically, our laboratory has the capability and experience with supporting multiple RCT sites for TMA (Gen-Probe) testing for gonorrhea, chlamydia, and trichomoniasis.  The staff’s extensive training and experience with vaginal wet mounts and Gram stains also means that they can provide quality assurance both internally (for Mombasa) and for other participating labs in Africa.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width:590px;\">\n <p>\n Key Personnel at Proposed Study Site:</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Title</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Name</p>\n </td>\n <td style=\"width:196px;\">\n <p>\n Qualification</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Site-Investigator</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n R. Scott McClelland, MD, MPH</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n See above qualifications</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Co-Investigators</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Walter Jaoko, MBChB, MMED, PHD</p>\n <p>\n  </p>\n <p>\n Kishorchandra Mandaliya, MBChB</p>\n <p>\n  </p>\n <p>\n Benson Estambale, MBChB, MMED</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The co-investigators have extensive women’s health research experience and have served as co-PI’s on a number of research studies including clinical trials in Mombasa.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Study Coordinator/Manager</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Jennifer Balkus, MPH</p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The study coordinator is experienced in clinical trials and women’s health research.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Research clinician(s)</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Ruth Gitau, MBChB</p>\n <p>\n  </p>\n <p>\n Vernon Mochache, MBChB</p>\n <p>\n  </p>\n <p>\n Linnet N. Masese, MBChB, MPH</p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The research clinicians are very experienced in women’s health and clinical research. They are well trained in screening, enrolling and retaining subjects for research studies.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Counselor</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Francis Kashonga</p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The counselor is very experienced in women’s health and clinical research. He is well trained in screening and enrolling subjects for research studies.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Nurses</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Esther Mutunga</p>\n <p>\n  </p>\n <p>\n Lucy Adala</p>\n <p>\n  </p>\n <p>\n Carol Ngacha</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The research nurses are very experienced in women’s health and clinical research.  They have extensive experience in screening, enrolling and retaining subjects for research studies.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Data manager</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Carol Mwalimu</p>\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The data manager is very experienced in providing data management support for clinical research, including randomized controlled trials.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Outreach staff</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n George Wanje</p>\n <p>\n  </p>\n <p>\n Jackie Ngina</p>\n <p>\n  </p>\n <p>\n Elizabeth Wanjiku</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The outreach staff are very experienced in recruiting and retaining participants for clinical research studies. </p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Laboratory staff</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Juma Shafi</p>\n <p>\n  </p>\n <p>\n Khamis Mwinyikai</p>\n <p>\n  </p>\n <p>\n Amina Abdalla</p>\n <p>\n  </p>\n <p>\n Emmanuel Kabare</p>\n <p>\n  </p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The laboratory staff have extensive training and experience with the laboratory procedures required for this study.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:204px;\">\n <p>\n Administrative staff</p>\n </td>\n <td style=\"width:190px;\">\n <p>\n Fatma Mwidadi</p>\n <p>\n  </p>\n <p>\n Jacqueline Dwallo</p>\n </td>\n <td style=\"width:196px;\">\n <p>\n The administrative staff are very experienced in providing administrative support for international clinical research studies.</p>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p class=\"p1\">\n The PVI trial will be conducted in the US as well as in 3 sites in Kenya. At all sites, the trial will include women with high rates of vaginal infections. This is the</p>\n<p class=\"p1\">\n population most likely to benefit from an intervention to reduce vaginal infections. The multisite international trial design is intended to enhance generalizability for</p>\n<p class=\"p1\">\n similar populations of women in a variety of settings.</p>\n
      • other_details_regulatory_notapproved<p>\n All regulatory authorities have granted approval for this study (see section 11.4 below)</p>\n
      • other_details_regulatory_approved<p class=\"p1\">\n Kenyan site approvals: </p>\n<p class=\"p1\">\n The University of Nairobi/Kenyatta National Hospital most recently approved the application for all three Kenyan sites on the following dates: </p>\n<ul>\n <li class=\"p1\">\n Kenya AIDS Vaccine Initative - 14 April 2013</li>\n <li class=\"p1\">\n Kenya AIDS Control Program - 17 March 2013</li>\n <li class=\"p1\">\n Mombasa HIV/STD Research Clinic - 16 March 2013</li>\n</ul>\n<p class=\"p1\">\n The University of Washington Institutional Review Board most recently approved the application for the Mombasa HIV/STD Research Clinic on 07 November 2012.</p>\n<p class=\"p1\">\n The Kenya Pharmacy and Poisons Board approved initial application for this trial on 23 June 2011 and has approved all subsequent progress reports. </p>\n<p class=\"p1\">\n  </p>\n<p class=\"p1\">\n US site approvals: </p>\n<p class=\"p1\">\n The University of Alabama Institutional Review Board most recently approved the University of Alabama site application on 13 June 2013.</p>\n<p class=\"p1\">\n The University of Washington Institutional Review Board most recently approved the  coordinating center application on 12 September 2012.</p>\n<p class=\"p1\">\n The US Food and Drug Administration approved our Investigational New Drug application (IND #110441) on 06 December 2010.</p>\n<p class=\"p1\">\n  </p>\n
      • other_details_regulatory_rejected<p class=\"p1\">\n No regulatory authorities or ethics committees have rejected this protocol.</p>\n
      • other_details_regulatory_halted<p class=\"p1\">\n This trial has not been halted at any stage for any reason.</p>\n
      • estimated_durationWe have allotted 12 months for participant accrual and 12 months of follow-up for each participant; therefore, we estimate the total duration of the trial to be 24 months.
      • 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
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
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      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites3
      • multi_country_listKenya (3 sites)\nUSA (1 site)
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKenya AIDS Vaccine Initiative - Kangemi = 59\nKenya AIDS Control Program - Korogocho = 59\nMombasa HIV/STD Research Clinic = 58
      • total_participants_worldwide234
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameRaymond
      • investigator1_middle_nameScott
      • investigator1_family_nameMcClelland
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressUniversity of Washington, Box 359909, 325 9th Ave, Seattle, WA, USA, 98104
      • investigator1_telephone+1 206 543-4278
      • investigator1_emailmcclell@uw.edu
      • organisations_transferred_Yes
      • number_participants176
      • notification<p>\n Attached are all progress reports and letters submitted to KPPB since the study received inital approval in 2011. </p>\n
      • approval_date23-06-2011
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-06-2013
      • is_child0
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      • initial_date_submitted(null)
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      • admin_stopped_reason(null)
      • approved2
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      • quantity_destroyed(null)
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      • balance_site(null)
      • final_date(null)
      • modified2014-02-05 20:54:44
      • created2013-06-07 18:56:12
      • total_sites(null)
      • ecitizen_invoice(null)
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        • middle_nameScott
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        • qualificationMD, MPH
        • professional_addressUniversity of Washington, Box 359909, 325 9th Ave, Seattle, WA, USA, 98104
        • telephone+1 206 543-4278
        • emailmcclell@uw.edu
        • created2013-06-07 19:12:02
        • modified2013-06-28 23:10:20
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        • physical_addressUniversity of Nairobi
        • contact_details+254 20 2725404
        • contact_personProf. Omu Anzala
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        • created2013-06-07 19:12:02
        • modified2013-06-28 23:10:20
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          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
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        • contact_details254 20 2713179 or 254 733 7197 11
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        • site_capacity(null)
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        • created2013-06-07 19:33:50
        • modified2013-06-28 23:10:20
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          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
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        • site_nameMombasa HIV/STD Research Clinic
        • physical_addressGanjoni Municipal Clinic, Mnazi Moja Road
        • contact_details+254 053 8015597
        • contact_personDr. Scott McClelland
        • site_capacity(null)
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        • created2013-06-07 19:33:50
        • modified2013-06-28 23:10:20
        • County(array)
          • id1
          • county_nameMombasa
          • created2012-05-31 16:15:11
          • modified2012-07-09 13:06:23
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        • id77
        • application_id150
        • sponsorUS National Institutes of Health, Department of Microbiology and Infectious Disease
        • sponsor_type(null)
        • contact_personPeter Wolff
        • addressDMID/NIAID/NIH/DHHS, 6610 Rockledge Drive Room 3111, Bethesda, MD, USA 20892
        • telephone_number+1 301 451-3741
        • fax_number
        • cell_number+1 301 451-3741
        • email_addresspwolff@niaid.nih.gov
        • created2013-06-07 19:12:02
        • modified2013-06-28 23:10:20
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