FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative
      women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to
      investigate the safety and effectiveness of a once-daily Truvada® pill (compared with
      placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through
      sexual intercourse.

      The study population included HIV-antibody-negative women between the ages of 18-35 who were
      at risk of HIV acquisition through sexual intercourse. Each participant was randomized to
      take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of
      emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical
      placebo.

      After enrollment, each participant was followed every four weeks. All participants were
      followed for an additional eight weeks after study drug was stopped. Incidence rates of HIV
      infection were compared between the two groups (active drug and placebo) using the
      intent-to-treat principle.
    

Detailed description: 
      This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative
      women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to
      investigate the safety and effectiveness of a once-daily Truvada® pill (compared with
      placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through
      sexual intercourse.

      The study population included HIV-antibody-negative women between the ages of 18-35 who were
      at risk of HIV acquisition through sexual intercourse. Each participant was randomized to
      take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of
      emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical
      placebo. All participants received risk reduction counseling and condoms. Women had to be
      using a study-approved effective non-barrier contraceptive method at the time of enrollment
      and were asked to do so for the whole period they were on study drug. They received
      contraceptive counseling throughout the study. Any diagnosed, treatable sexually transmitted
      infection was treated free of charge.

      After enrollment, each participant was followed every four weeks. All participants were
      followed for an additional eight weeks after study drug was stopped. Participants at risk for
      Hepatitis B Virus (HBV) flare were followed every four weeks for 12 weeks after stopping
      study product. Participants who acquired HIV infection during the study stopped taking the
      study drug at the time of HIV diagnosis, and will be followed for 52 weeks post diagnosis and
      were referred for care and treatment. Participants who became pregnant stopped taking the
      study drug but continued follow-up visits. Incidence rates of HIV infection were compared
      between the two groups (active drug and placebo) using the intent-to-treat principle.
    

Intervention name(s): Truvada; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Daily single oral tablet of Truvada - a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).; Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Other intervention name(s): TDF/FTC - emtricitabine and tenofovir disoproxil fumarate
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Aspartate Aminotransferase (AST); Alanine Aminotransferase (ALT); HIV; HIV Prevention; Oral PrEP; Truvada; women; Tenofovir; TDF; FTC; emtricitabine; hepatitis; Pre-exposure Prophylaxis (PrEP); HIV Seronegativity