Pre-Exposure Prophylaxis
Trial: Study to assess the role of Truvada® in preventing HIV acquisition in women [FEM-PrEP]
Phase: III
Product Being Tested: Daily oral TDF/FTC (Truvada®)
Sponsor, funder, developer, collaborator: FHI; United States Agency for International Development; Bill and Melinda Gates Foundation; Bondo Clinic, Bondo District Hospital
Total participants: 3,900
Countries: Kenya, Malawi, South Africa, Tanzania, Zambia
Trial sites in Kenya: Nyanza
Results expected: 2013
For more information: http://clinicaltrials.gov/ct2/show/NCT00625404
Trial: Pre-Exposure Prophylaxis to prevent HIV-1 acquisition within HIV-1 discordant couples [PartnersPrEP]
Phase: III
Product Being Tested: Daily oral TDF & daily oral TDF/FTC
Sponsor, funder, developer, collaborator: Bill and Melinda Gates Foundation; Moi University - Indiana University; Kenyatta National Hospital/University of Nairobi; CMR, Kemri-UCSF; Partners in Prevention - Thika
Total participants: 4,700
Countries: Kenya, Uganda
Trial sites in Kenya: Eldoret, Nairobi, Kisumu, Thika
Results expected: 2012
For more information: http://clinicaltrials.gov/ct2/show/NCT00557245
Trial: A pilot study of Pre-Exposure Prophylaxis (PrEP) to evaluate safety, acceptability, and adherence in at-risk populations in Kenya [IAVI E001]
Phase: I/II
Product Being Tested: Daily oral TDF/FTC; intermittent oral TDF/FTC (twice weekly + coital dosing)
Sponsor, funder, developer, collaborator: International AIDS Vaccine Initiative; Gilead Science, Inc; KEMRI-CGMRC, Kilifi, Kenya; KAVI-Kangemi, Kenya
Total participants: 72
Countries: Kenya, Uganda
Trial sites in Kenya: Kilifi, Kangemi
Results expected: Q4 2010
For more information: https://www.iavi.org/research-development/trials/pages/prepstudy.aspx
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Partner Treatment
Trial: Evaluation of the effectiveness of two antiretroviral treatment strategies to prevent HIV transmission in HIV-serodiscordant couples [HPTN 052]
Phase: III
Product Being Tested: Highly active antiretroviral therapy for HIV prevention
Sponsor, funder, developer, collaborator:HIV Prevention Trials Network, Gaborone Prevention/Treatment Trials CRS
Total participants: 1,750 couples
Countries: Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, US, Zimbabwe
Trial sites in Kenya: Kisumu
Results expected: n/a
For more information: http://www.hptn.org/research_studies/hptn052.asp
Trial: Safety and acceptability trial of dapivirine gel, conducted using daily monitored adherence in healthy HIV-negative women [IPM014A/B]
Phase: I/II
Product Being Tested: Dapivirine gel
Sponsor, funder, developer, collaborator: International Partnership for Microbicides, Kenya Medical Research Institute
Total participants: 320
Countries: Kenya, Malawi, Rwanda, South Africa, Tanzania
Trial sites in Kenya: Kisumu
Results expected: July 2012
For more information: http://clinicaltrials.gov/ct2/show/NCT00917904?term=IPM014B&rank=1