Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
481. |
ECCT/14/09/01 | Extension to study MALARIA-055 PRI (110021) for evaluation of long-term efficacy, safety and immunogenicity of GSK Biologicals’candidate malaria vaccine (SB257049) in infants and children in Africa An open extension to the phase III, multi-center study MALARIA-055 PRI (110021) to evaluate long-term efficacy, safety and immunogenicity of the RTS,S/AS01E candidate vaccine against malaria disease caused by Plasmodium falciparum in infants and children in Africa. Study number: MALARIA-076 (200599) |
Principal Investigator(s) 1. Walter Otieno Site(s) in Kenya Kenya Medical Research Institute/Walter Reed Project |
23-09-2015 |
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482. |
ECCT/15/06/01 | Pyronaridine-artesunate and artemether-lumefantrine for the treatment of paediatric uncomplicated falciparum malaria in Western Kenya |
Principal Investigator(s) 1. Patrick Sawa Site(s) in Kenya St. Judes Clinic, ICIPE |
04-09-2015 |
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483. |
ECCT/14/09/03 | Breast Feeding Study An open-label, short-duration, repeat-dose study of breast milk excretion and infant absorption of daily oral Tenofovir Disoproxil Fumarate/Emtricitabine when used by HIV-1 uninfected lactating women |
Principal Investigator(s) 1. Jared Murray Baeten 2. Nelly Rwamba Mugo Site(s) in Kenya Partners in Prevention, Thika Site |
19-08-2015 |
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484. |
ECCT/14/08/03 | STAND Study (Shortening Treatment by Advancing Novel Drugs) Long Title: A Phase 3 Open Label Partially Randomised Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin plus PA-824 plus Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects with Drug Sensitive Smear Positive Pulmonary Tuberculosis and after 6 months of Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis Short Title: STAND Study (Shortening Treatment by Advancing Novel Drugs) |
Principal Investigator(s) 1. Dr Videlis Nduba 2. Dr Evans Amukoye Site(s) in Kenya 1. KEMRI-CRDR(East Nairobi) (Nairobi City county) 2. KEMRI-CRDR(West Nairobi) (Nairobi City county) |
17-08-2015 |
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485. |
ECCT/15/06/02 | ZINC in Sickle cell study The effects of Zinc supplementation in children with sickle cell disease in Western Kenya: a pilot study. |
Principal Investigator(s) 1. Lucas Otieno Tina Site(s) in Kenya Health Facilities in Western Kenya |
17-08-2015 |
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486. |
ECCT/15/06/03 | DolutegrAvir With NRTIs as second-line treatment (DAWNING) A Phase 3b, randomised, open-label study of the antiviral activity and safety of dolutegravir compared to lopinavir/ritonavir both administered with dual nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected adult subjects with treatment failure on first line therapy |
Principal Investigator(s) 1. Dr. Evans Inyangala Amukoye 2. Dr. Maricianah Atieno Onono Site(s) in Kenya 1. Center for Respiratory Diseases Research, CRDR, KEMRI, Nairobi (Nairobi City county) 2. KEMRI-Research Care and Training Program (RCTP), Family AIDS Care and Education Services (FACES), Lumumba health centre (Kisumu county) |
29-07-2015 |
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487. |
ECCT/15/03/01 | A phase III, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering A phase III, randomized, double-blind, active, controlled, multinational, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally. |
Principal Investigator(s) 1. Zahida Qureshi Site(s) in Kenya Kenyatta National Hospital |
27-07-2015 |
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488. |
ECCT/15/06/04 | A5316 A5316 Evaluating Pharmacokinetic Interactions with Vaginal Ring Contraceptives and Antiretroviral Therapy |
Principal Investigator(s) 1. Dr. Esther Mumbi Makanga Makanga 2. Dr. Victor Akelo Akelo 3. Dr.Victor O. Mudhune Mudhune 4. Dr. Kevin P. Cain Cain Site(s) in Kenya KEMRI- CDC |
17-07-2015 |
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489. |
ECCT/15/04/02 | Plasma concentration profiles after oral administration of oleylphosphocholine tablet formulation: safety, tolerability and pharmacokinetics of 100 mg single dose in healthy male volunteers. |
Principal Investigator(s) 1. Ravasco Rashid Juma Site(s) in Kenya KEMRI |
15-06-2015 |
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490. |
ECCT/15/01/03 | Simplifying ShangRing Circumcision for Men and Boys Simplifying the Shang Ring Technique for Circumcision of Men and Boys |
Principal Investigator(s) 1. Mark Barone Site(s) in Kenya 1. Homa Bay Level IV hospital (Homa Bay county) 2. Vipingo Health Centre (Kilifi county) |
15-04-2015 |
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