Clinical Trial Applications: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | |
|---|---|---|---|---|
21. |
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) |
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22. |
ECCT/11/08/05 | Rifapentine During Intensive Phase TB Treatment Evaluation of a rifapentine-containing regimen for intensive phase treatment of pulmonary tuberculosis |
Principal Investigator(s) 1. Lena Matata 2. Kevin Cain Site(s) in Kenya KEMRI/CDC-KISUMU |
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23. |
ECCT/11/09/01 | Randomized Comparison of ART Alone versus ART with Immediate Chemotherapy A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS) |
Principal Investigator(s) 1. Deborah C. Langat Site(s) in Kenya KEMRI/Walter Reed Project |
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24. |
ECCT/11/10/01 | A RANDOMIZED PHASE IIA TRIAL OF GEMCITABINE COMPARED WITH BLEOMYCIN PLUS VINCRISTINE FOR TREATMENT OF KAPOSI’S SARCOMA IN PATIENTS ON COMBINATION ANTIRETROVIRAL THERAPY IN WESTERN KENYA. |
Principal Investigator(s) 1. NAFTALI WISINDI BUSAKHALA Site(s) in Kenya MOI UNIVERSITY CLINICAL RESEARCH SITE |
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25. |
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) |
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