Pharmacy and Poisons Board

Pharmacy and Poisons Board

Ensuring Safety, Quality and Efficacy of Medicines

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Page 1 of 6, showing 5 Applications out of 27 total, starting on record 1, ending on 5

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

1.

ECCT/17/08/05   Phase I Safety and Pharmacokinetic Study of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection.
    Phase I Safety and Pharmacokinetic Study of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection.   
Principal Investigator(s)
1. Isaac Tsikhutsu
Site(s) in Kenya
Kenya Medical Research Institute/Walter Reed Project HIV Program, Kericho
 
Trial Status not yet recruiting
Protocol Date 13-04-2016
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2.

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 In follow-up
Protocol Date 02-12-2016
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3.

ECCT/17/05/03   TDF IVR-002 Study
    Phase 1 Safety and Pharmacokinetic Study of a Polyurethane Tenofovir Disoproxil Fumarate Vaginal Ring in Sexually Active Women (TDF IVR-002)   
Principal Investigator(s)
1. Nelly Rwamba Mugo
Site(s) in Kenya
Partners in Health Research & Development (Thika Partners Clinical Trial Site)
 
Trial Status stopped
Protocol Date 30-08-2016
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4.

ECCT/16/11/02   IMPAACT P1093
    Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and AdolescentsPhase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents   
Principal Investigator(s)
1. Lucy Koech
Site(s) in Kenya
KENYA MEDICAL RESEARCH INSTITUTE/WALTER REED PROJECT HIV PROGRAME
 
Trial Status recruiting
Protocol Date 13-04-2016
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5.

ECCT/16/08/03   IMPAACT 2001
    A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection   
Principal Investigator(s)
1. Deborah Chepngeno Langat
Site(s) in Kenya
Kenya Medical Research Institute Walter Reed project
 
Trial Status recruiting
Protocol Date 10-11-2015
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