NCT00557245

Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,758 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• HIV-1 Infections
• HIV Infections

Interventions

Type	Name	Description
DRUG	Tenofovir Disoproxil Fumarate (TDF)	TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
DRUG	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
DRUG	Placebo	Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2007-11-12
• Last updated: 2019-04-19
• Results posted: 2014-11-27

Locations

9 sites across 2 countries: Kenya, Uganda