Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
531. |
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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532. |
ECCT/08/08/03 | Partners PrEP Study Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples. |
Principal Investigator(s) 1. Prof. Connie Celum Site(s) in Kenya 1. Kenya- Eldoret (Uasin Gishu county) 2. Kenya – Nairobi (Nairobi City county) 3. Kenya – Kisumu (Kisumu county) 4. Kenya – Thika (Uasin Gishu county) |
12-11-2008 |
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533. |
ECCT/13/07/05 | Single Dose Escalating, Single-blind Phase 1 Trial in Healthy Male Volunteers to Evalute the Safety, Tolerability and the Pharmacokinetics of Oleylphosphocholine. |
Principal Investigator(s) 1. Rashid Ravasco Juma Site(s) in Kenya KEMRI Centre for Clinical Research |
25-06-2013 |
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534. |
ECCT/11/08/03 | Compare the Efficacy and Safety of Gentian Violet to that of Nystatin 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 |
Principal Investigator(s) 1. Deborah C Langat Site(s) in Kenya 1. Kenya Medical Research Institute Walter Reed Project Clinical Research Centre (Kericho county) 2. Moi University Clinical Research Centre (Uasin Gishu county) |
22-11-2012 |
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535. |
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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536. |
ECCT/10/11/06 | Randomized Comparison of ART Alone versus ART with Immediate Chemotherapy A5264/AMC 067 "A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of Li1mited Stage AIDS-KS in Resource-Limited Settings (REACT-KS)" |
Principal Investigator(s) 1. Abraham Mosigisi Siika Site(s) in Kenya 1. Walter Reed Project Kericho (Kericho county) 2. Moi University Clinical Research Centre (Uasin Gishu county) |
04-08-2010 |
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537. |
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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538. |
ECCT/13/08/01 | M72/AS01 E A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals’ candidatetuberculosis (TB) vaccine GSK 692342 against TB disease, in healthy adults aged 18-50 years, living in a TB endemic region. |
Principal Investigator(s) 1. Dr Videlis Nduba Site(s) in Kenya KEMRI-CDC |
06-08-2013 |
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539. |
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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540. |
ECCT/09/03/01 | REMoxTB A randomised placebo – controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol, isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely 1) two months moxifloxacin, isoniazid, rifampicin and pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and 2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis |
Principal Investigator(s) 1. Evans Inyangala Amukoye Site(s) in Kenya Kibera D.O Health Centre |
01-07-2013 |
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