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Status
Completed
Phase
III
Principal Investigator(s)
Connie Celum
Objective
Demonstrate if PrEP decreases HIV-1 acquisition among HIV uninfected individuals within HIV-1 discordant couples.
Prevention Option(s)
PrEP
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily
Mode of Delivery
Tablet
Products
TDF
ARMs
Experimental
Description
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily
ARMs
Experimental
Official Code
Trial Sponsors
Bill and Melinda Gates Foundation, University of Washington
May 2008
October 2010
Enrollment
4 758
18
Years
65
Years
Population
Women
Men
Sites
Moi University - Indiana University
Eldoret
Kenya
CMR, Kemri-UCSF
Kisumu
Kenya
Kenyatta National Hospital/University of Nairobi
Nairobi
Kenya
Partners in Prevention - Thika
Thika
Kenya
Kabwohe Clinical Research Center
Bushenyi
Uganda
Infectious Diseases Institute
Jinja
Uganda
Partners House-Infectious Disease Institute Ltd
Kampala
Uganda
The AIDS Support Organization (TASO)
Mbale
Uganda
The AIDS Support Organization - Tororo Field Station
Tororo
Uganda