pre-exposure prophylaxis to prevent hiv-1 acquisition within hiv-1 discordant couples

Conditions: HIV-1 Infections; HIV Infections

Summary: 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.

Eligibility criteria:
inclusion criteria for hiv-1 uninfected partner: * partner within an hiv-1 discordant heterosexual relationship * one partner meets study eligibility for hiv-1 uninfected study participant and the other partner meets study eligibility criteria for hiv-1 infected participant * plan to remain in the relationship for the duration of the study period * adequate renal, hepatic \& hematologic function * negative hepatitis b surface antigen test * willing and able to provide written informed consent \& locator information exclusion criteria for hiv-1 uninfected partner: * current pregnancy, or planning to become pregnant during the study period * currently breastfeeding * concurrent enrollment in another hiv-1 vaccine or prevention trial * receiving ongoing antiretroviral therapy * repeated positive urine dipstick tests for glycosuria or proteinuria * active and serious infections * history of pathological bone fractures not related to trauma inclusion criteria for hiv-1 infected partner: * partner within an hiv-1 discordant heterosexual relationship * one partner meets study eligibility for hiv-1 uninfected study participant and the other partner meets study eligibility criteria for hiv-1 infected participant * hiv-1 infected based on positive eia * no history of any clinical aids-defining diagnoses * plan to remain in the relationship for the duration of the study period * willing and able to provide written informed consent \& locator information exclusion criteria for hiv-1 infected partner: * current use of antiretroviral therapy * concurrent enrollment in another hiv-1 treatment trial

Keywords: hiv infection hiv uninfected partners double blind placebo seroconversion tdf ftc tdf safety hiv seronegativity