HIV Infections Clinical Trial
Official title:
Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
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.
HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high-risk for
HIV-acquisition. The majority of HIV-1 transmissions to adults in Africa occur within stable,
HIV-1 discordant couples.
Pre-exposure chemoprophylaxis, in which an HIV-1 uninfected individual at high risk for
contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels
sufficient to prevent HIV-1 acquisition, has been proposed as a potential HIV-1 prevention
strategy.
This study was a 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. The HIV-1 uninfected partner was randomized in a 1:1:1 ratio to one of
three arms: once daily Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir
Disoproxil Fumarate (FTC/TDF) or Placebo.
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.
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