Pharmacy and Poisons Board

Pharmacy and Poisons Board

Ensuring Safety, Quality and Efficacy of Medicines

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Page 4 of 39, showing 5 Applications out of 192 total, starting on record 16, ending on 20

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


ECCT/17/08/07   Tambua Mapema Plus
    Impact of a novel HIV-1 RNA testing intervention to detect acute and prevalent HIV infection and reduce HIV transmission – Tambua Mapema Plus   
Principal Investigator(s)
1. Eduard J Sanders
2. Susan M Graham
Site(s) in Kenya
KEMRI Mtwapa
Trial Status (not set!)
Protocol Date 06-03-2017


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


ECCT/17/08/02   IMPROVE (Improving PRegnancy Outcomes with intermittent PReVEntive treatment in Africa)
    IPTp with dihydroartemisinin-piperaquine and azithromycin for malaria, sexually transmitted and reproductive tract infections in pregnancy in high sulphadoxine-pyrimethamine resistance areas in Kenya, Malawi and Tanzania: an international multi-centre 3-arm placebo-controlled trial   
Principal Investigator(s)
1. Simon Kariuki
Site(s) in Kenya
1. Migori County Referral Hospital (Migori county)
2. Homa Bay County Referral Hospital (Homa Bay county)
3. Rongo Sub-County Hospital (Migori county)
4. Ahero Sub-County Hospital (Kisumu county)
5. Rabuor Sub-County Hospital (Kisumu county)
Trial Status recruiting
Protocol Date 01-05-2017


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
Trial Status In follow-up
Protocol Date 02-12-2016


ECCT/17/08/01   A trial to compare the safety and immune response of the normal full and reduced doses of yellow fever vaccines in Kenyan adults
    A Phase IV randomized, double blinded non-inferiority trial on the immunogenicity and safety of fractional doses of yellow fever vaccines.   
Principal Investigator(s)
1. Philip Bejon
Site(s) in Kenya
KEMRI Kilifi
Trial Status In follow-up
Protocol Date 20-04-2017