HPTN 059

Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel

Study Summary
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What was HPTN 059?

A Phase II four arm, three site randomized, controlled trial to assess the safety of tenofovir gel for vaginal use in HIV-uninfected women versus a placebo gel

Who participated in the study?

200 sexually active, HIV-uninfected women between the ages of 18 and 50, but not menopausal or post menopausal.

What happened during the study?

Once enrolled, participants were randomized into either the once daily or the coitally dependent group, and received either tenofovir or placebo gel. Participants received single use unit dose tube and single use applicator to be filled by the participant to be used either once daily or with each act of intercourse. Throughout the study, participants received ongoing condom counseling and free condoms.

Study Documents