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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Bill and Melinda Gates Foundation
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

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