Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
551. |
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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552. |
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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553. |
ECCT/12/09/02 | Reduction of EArly mortaLITY in adults and children Reduction of EArly mortaLITY in HIVinfected adults and children starting antiretroviral therapy (REALITY) |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Moi University Clinical Research Centre (Uasin Gishu county) 2. KEMRI Wellcome Trust Research Programme (Kilifi county) |
04-04-2012 |
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554. |
ECCT/12/04/01 | A double-masked randomised placebo-controlled trial of adjuvant topical 5-fluorouracil (5FU) treatment following surgical excision of ocular surface squamous neoplasia. |
Principal Investigator(s) 1. Stephen Gichuhi Site(s) in Kenya 1. Kenyatta National Hospital (Nairobi City county) 2. PCEA Kikuyu Eye Unit (Kiambu county) 3. Sabatia Eye Hospital (Kakamega county) 4. Kitale District Hospital, Eye Unit (Trans Nzoia county) 5. Homa Bay District Hospital, Eye Unit (Homa Bay county) |
15-03-2012 |
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555. |
ECCT/12/11/02 | Not provided A5297: An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium falciparum Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and <350 cells/mm3 |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Moi University Clinical Research Centre (Uasin Gishu county) |
29-02-2012 |
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556. |
ECCT/12/11/03 | Rifampin-Based TB Treatment vs. Rifabutin-Based TB Treatment in HIV A5290 "A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis Treatment with or without Raltegravir in HIV-1-Infected Persons Requiring Treatment for Active TB and HIV" |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Moi University Clinical Research Centre (Uasin Gishu county) |
31-01-2012 |
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557. |
ECCT/13/07/03 | Pharmacokinetic and pharmacodynamic studies of efficacy, tolerability and safety of higher dosage rifapentine for treatment of tuberculosis |
Principal Investigator(s) 1. Dr Lena Matata Site(s) in Kenya KEMRI-CDC |
07-12-2011 |
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558. |
ECCT/11/10/05 | A Phase 3, Open Label, Randomized, Comparative Study to Evaluate Azithromycin Plus Chloroquine and Sulfadoxine Plus Pyrimethamine Combinations for Intermittent Preventive Treatment of Falciparum Malaria Infection in Pregnant Women in Africa. WRAIR #1775, KEMRI SSC #1983 |
Principal Investigator(s) 1. Lucas Otieno Tina Site(s) in Kenya 1. KEMRI/WRP Kombewa (Kisumu county) |
25-11-2011 |
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559. |
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 |
02-11-2011 |
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560. |
ECCT/12/07/01 | MULTI-OCTAVE (Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure) A5288 "Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure" (MULTI-OCTAVE) |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya Moi University Clinical Research Centre |
16-09-2011 |
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