Purpose: To assess the safety and effectiveness of tenofovir gel, a candidate vaginal microbicide, in sexually active women at risk for human immunodeficiency virus (HIV) infection in South Africa.~Design: Phase IIb, two-arm, double-blind, randomised, controlled trial comparing 1% tenofovir gel with a placebo gel.~Study Population: Sexually active, HIV-uninfected women aged 18 to 40 years in South Africa~Study Size: 900 women~Treatment Regimen: Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel or placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.~Study Duration: Approximately 30 months in total. Accrual will require approximately 14 months and follow-up will continue until 92 incident HIV infections are observed in the study, which is expected to occur approximately 16 months after the end of the accrual period.~Primary Objective:~To evaluate the effectiveness and safety of a candidate vaginal microbicide, tenofovir gel, when applied intravaginally by women, in preventing sexually transmitted HIV infection.~Secondary Objectives:~To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption~To assess the impact, if any, of tenofovir gel on viral load in women who become infected with HIV during the trial.~To assess tenofovir resistance in HIV seroconvertors in the trial~To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes~To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance~Ancillary Objective~•To assess the impact, if any, of tenofovir gel in preventing sexually transmitted infections, including herpes simplex virus type 2 (HSV-2) and human papillomavirus (HPV) infections.~Study sites:~CAPRISA Vulindlela Clinical Research Site, KwaZulu-Natal, South Africa~CAPRISA eThekwini Clinical Research Site, Durban, South Africa
This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.