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Status
Completed
Phase
III
Principal Investigator(s)
Connie Celum, Jared Baeten
Objective
Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.Couples were followed up to 36 months; the HIV uninfected partner attended monthly visits and the HIV infected partner quarterly visits. All participants received a comprehensive package of HIV prevention services including individual and couples counseling, free condoms, and male circumcision referrals.
Participants who seroconverted during follow-up stopped the study drug but continued with follow-up.
Key results: Reduction in HIV infection rate on
1) Daily oral TDF - Women 71%, Men 63%;
2) Daily oral TDF/ FTC - Women 66%, Men 84%
Last updated August 10, 2022
Prevention Option(s)
PrEP
Study Design
Controlled
Placebo-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
Related Publications
Trial Sponsors
Bill and Melinda Gates Foundation, University of Washington
May 2008
October 2013
Date of Enrollment Completion
October 1, 2013
Enrollment
4 758
18
Years
65
Years
Population
Men
Women
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