FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
FHI 360
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir