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 48 total, starting on record 1, ending on 5

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

1.

ECCT/17/08/09   A trial to compare two new combinations of antimalarial drugs with the standard combination of antimalarial drugs in Kenyan children
    An open-label randomised trial to assess the therapeutic efficacy and tolerability of arterolane-piperaquine plus single low dose primaquine versus arterolane-piperaquine plus mefloquine and single low dose primaquine versus artemether-lumefantrine plus single low dose primaquine in the treatment of uncomplicated falciparum malaria in children in Kenya.   
Principal Investigator(s)
1. Philip Bejon
Site(s) in Kenya
1. Kilifi County Hospital - Paediatric Out patient and Inpatient department (Kilifi county)
2. Pingilikani Dispensary (Kilifi county)
 
Trial Status (not set!)
Protocol Date 30-06-2017
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2.

ECCT/17/09/03   A5354
    Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses   
Principal Investigator(s)
1. Deborah Langat
Site(s) in Kenya
Kenya Medical Research Institute Walter Reed Project Clinical Research Centre
 
Trial Status (not set!)
Protocol Date 19-04-2016
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3.

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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4.

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 yet recruiting
Protocol Date 18-12-2015
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5.

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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