Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Condition: HIV-1 Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections
Intervention: Tenofovir Disoproxil Fumarate (TDF); Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF); Placebo
Intervention description: TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.; FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily; Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4758.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV infection; HIV uninfected partners; Double Blind; Placebo; Seroconversion; TDF; FTC TDF; Safety; HIV Seronegativity

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.
    

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