Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
551. |
ECCT/11/10/04 | Treatment of Advanced AIDS-KS in Resource-Limited Settings A5263/AMC 066 "A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings" |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Moi University Clinical Research Centre (Uasin Gishu county) 2. KEMRI Walter Reed Project (Kericho county) |
07-08-2012 |
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552. |
ECCT/13/07/04 | Advanced Kapsosis Sarcoma Chemotherapy Regimens A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings |
Principal Investigator(s) 1. Josphat Kosgei Site(s) in Kenya 1. WRP/KEMRI - Kericho (Kericho county) 2. AMPATH - MOI University Teaching Hospital Eldoret CRS (Uasin Gishu county) |
07-08-2012 |
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553. |
ECCT/13/04/08 | Switching At Low HIV-1 RNA Into Fixed Dose Combinations SALIF Protocol Number: TMC278IFD3002 Amendment INT-1 |
Principal Investigator(s) 1. Edwin Onyango WERE 2. Milton Tony OMONDI 3. Gina OUATTARA 4. Gaudensia Nzembi MUTUA 5. Reena SHAH Site(s) in Kenya 1. Aga Khan University Hospital (Nairobi City county) 2. KEMRI/Walter-Reed Project Kombewa (Kisumu county) 3. Partners in Prevention (Uasin Gishu county) 4. Kenya AIDS Vaccine Initiative - KNH (Nairobi City county) 5. Kenya AIDS Vaccine Initiative - Kangemi (Nairobi City county) |
30-07-2012 |
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554. |
ECCT/13/03/02 | An open-label, pilot demonstration and evaluation project of antiretroviral-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples An open-label, pilot demonstration and evaluation project of antiretroviral-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples The Partners PrEP Study Demonstration Project |
Principal Investigator(s) 1. DR.ELIZABETH ANNE BUKUSI ELIZABETH ANNE BUKUSI Site(s) in Kenya 1. THIKA (Nairobi City county) |
10-07-2012 |
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555. |
ECCT/09/06/02 | A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 In Serodiscordant Couples |
Principal Investigator(s) 1. Lisa Ann Mills Site(s) in Kenya Kisumu, Kenya |
05-07-2012 |
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556. |
ECCT/12/09/03 | REALITY Trial Reduction of EArly mortaLITY in HIV-infected adults and children starting antiretroviral therapy |
Principal Investigator(s) 1. DR ANTHONY OLIWA ETYANG Site(s) in Kenya 1. KEMRI Wellcome Trust Research Programme (Kilifi county) 2. Moi University School of Medicine, Academic Model for the Prevention and Treatment of HIV/AIDS (AMPATH) Centre at Moi Teaching Referral Hospital (MTRH) (Uasin Gishu county) |
05-07-2012 |
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557. |
ECCT/12/02/02 | HIV/HPV-Adolescent Study Immunogenicity and Safety of quadrivalent human Papillomavirus Vaccine in HIV-Infected pre-adolescent girls and boys in Kenya. |
Principal Investigator(s) 1. Dr. Nelly Rwamba Mugo Site(s) in Kenya Thika |
22-05-2012 |
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558. |
ECCT/12/03/01 | Role of Fish Oil Omega-3 Fatty Acids on Depression among HIV-Seropositive Pregnant Women in Nairobi: A Randomized Double-blind Controlled Trial |
Principal Investigator(s) 1. Rose Okoyo Opiyo Site(s) in Kenya 1. Riruta Health Centre (Nairobi City county) 2. Kariobangi North Health Centre (Nairobi City county) 3. Mathare North Health Centre (Nairobi City county) 4. Kayole II Sub-district hospital (Nairobi City county) |
22-05-2012 |
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559. |
ECCT/11/08/04 | SSG/PM Pharmacovigilance Plan Pharmacovigilance Plan to Monitor the Safety and Effectiveness of Combination of Sodium Stibogluconate and Paramomycin in the Treatment of Visceral Leishmaniasis 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. 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 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. 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. 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. 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. |
Principal Investigator(s) 1. Monique Wasunna Site(s) in Kenya 1. Kacheliba Kala-azar treatment centre (West Pokot county) 2. Kimalel Health Centre (Baringo county) |
13-05-2012 |
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560. |
ECCT/10/03/03 | High-Dose Fluconazole Treatment in AIDS-Associated CM A5225/HiFLAC: A Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Moi University Clinical Research Centre (Uasin Gishu county) |
11-05-2012 |
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