Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection

Phase 3 Completed 2059 enrolled CONRAD Follow-on African Consortium for Tenofovir Studies (FACTS) · collab United States Agency for International Development (USAID) · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study is to assess the safety and effectiveness of intravaginal 1% tenofovir gel in preventing Human Immunodeficiency Virus (HIV-1) infection and Herpes Simplex Virus (HSV-2) infection in sexually active women.

Timeline

Start: 2011-10
Primary completion: 2014-08
Completion: 2014-08

Outcome

Missed primary endpoint

paper Overall, pericoital tenofovir gel did not prevent HIV-1 acquisition in this population of young women at risk of HIV infection in South Africa. PMID 30507409 ↗

Publications

Delany-Moretlwe S, Lombard C, Baron D, Bekker LG, Nkala B, Ahmed K, Sebe M, Brumskine W, Nchabeleng M, Palanee-Philips T, Ntshangase J, Sibiya S, Smith E, Panchia R, Myer L, Schwartz JL, Marzinke M, Morris L, Brown ER, Doncel GF, Gray G, Rees H. Tenofovir 1% vaginal gel for prevention of HIV-1 infection in women in South Africa (FACTS-001): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2018 Nov;18(11):1241-1250. doi: 10.1016/S1473-3099(18)30428-6. Epub 2018 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenofovir	Small molecule	40 mg	Other

Indications

No indication recorded.