Partners PrEP

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, Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionTDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily
Mode of DeliveryTablet
ARMsExperimental
DescriptionFTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Mode of DeliveryTablet
ARMsExperimental
Results: Antiretroviral prophylaxis for HIV prevention in heterosexual men and women
Official Code: NCT00557245
Related Publications:
Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention
Daily oral tenofovir and emtricitabine-tenofovir preexposure prophylaxis reduces herpes simplex virus type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a ran
Trial Sponsors: Bill & Melinda Gates Foundation, University of Washington
Start Date
End Date
May 31, 2008
October 1, 2013
Enrollment:4,758
Age range: 18 Years ↔ 65 Years
Population:Cisgender Men, Cisgender Women