Pharmacy and Poisons Board

Pharmacy and Poisons Board

Ensuring Safety, Quality and Efficacy of Medicines

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Page 1 of 10, showing 5 Applications out of 46 total, starting on record 1, ending on 5

# Protocol No Study Title Investigator(s) & Site(s) Application Status

1.

ECCT/17/08/03   Efficacy and safety of KAF156 in combination with LUM-SDF in adults and children with uncomplicated Plasmodium falciparum malaria
    A Phase 2 interventional, multicenter, randomized open-label study to determine the effective and tolerable dose of KAF156 and Lumefantrine Solid Dispersion Formulation in combination, given once daily for 1, 2 and 3-days to adults and children with uncomplicated Plasmodium falciparum malaria.           
Principal Investigator(s)
1. Grace Kiringa Kaguthi
Site(s) in Kenya
KEMRI Siaya
 
Trial Status (not set!)
Protocol Date 14-02-2017
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2.

ECCT/17/06/02   PAINT Study
    A Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of rilpivirine (TMC278) in antiretroviral-naïve HIV-1 infected adolescents and children aged ≥6 to <18 years   
Principal Investigator(s)
1. Isaac Tsikhutsu
Site(s) in Kenya
1. Kenya Medical Research Institute/Walter Reed Project, HIV Program (Kericho county)
2. KAVI Institute of Clinical Research (Nairobi City county)
 
Trial Status (not set!)
Protocol Date 18-12-2015
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3.

ECCT/17/05/04   Ad26.Mos4.HIV Prime/Ad26.Mos4.HIV with Clade C gp140 plus adjuvant +/- Mosaic boost
    A randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in healthy HIV-uninfected adults to assess safety/tolerability and immunogenicity of 2 different prime/boost regimens: priming with tetravalent Ad26.Mos4.HIV and boosting with tetravalent Ad26.Mos4.HIV and either Clade C gp140 plus adjuvant OR a combination of Mosaic and Clade C gp140 plus adjuvant   
Principal Investigator(s)
1. Josphat Kosgei
Site(s) in Kenya
KEMRI WALTER REED KERICHO
 
Trial Status not yet recruiting
Protocol Date 02-12-2016
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4.

ECCT/16/11/04   RV456
    A Randomized, Observer-blind, Placebo-controlled, Two part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo   
Principal Investigator(s)
1. JANET OYIEKO
Site(s) in Kenya
KOMBEWA CLINICAL RESEARCH CENTRE
 
Trial Status recruiting
Protocol Date 08-03-2016
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5.

ECCT/16/11/05   RV 456: Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo
    A randomized, obsever-blind, placebo controlled, two-part, Phase 2 study to evaluate the Safety, Tolerability and Immunogenicity of Two prime-boost regimen of the candidate Prophylactic vaccines for Ebola Ad26-ZEBOV and MVA-BN Filo.   
Principal Investigator(s)
1. Fredrick Kipyego Sawe
Site(s) in Kenya
1. KEMRI/WRP Kericho (Kericho county)
2. KEMRI/WRP Kombewa, Kisumu (Kisumu county)
 
Trial Status recruiting
Protocol Date 08-03-2016
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