Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel
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
Study Details
To assess the safety of tenofovir gel for vaginal use in HIV-uninfected women versus a placebo gel.
Phase II four arm, three site randomized, controlled trial comparing tenofovir 1 % vaginal gel used once daily and tenofovir 1% vaginal gel used prior to intercourse, to a placebo gel study, with 6 months tenofovir gel exposure and follow-up. Participants who are HBV positive will return to site at visits Weeks, 28, 32, and 36 (post product use). Participants in all four arms will receive ongoing condom counseling and free condoms. The study will be conducted at thee sites; Pune, India; Alabama, Birmingham, USA; New York, USA.
The proposed study population will consist of up to 200 sexually active, HIV-uninfected women between the ages of 18 and 50, but not menopausal or post menopausal.
The Pune, UAB, and New York sites will enroll a total of 200 women.
Six months of tenofovir gel exposure and six months follow-up. HBV positive participants will be followed at 4, 8 and 12 weeks post exposure to monitor for rebound. Consequently study duration will be six to nine months.
Once enrolled, participants will be randomized into either the once daily or the coitally dependent group, and will receive either tenofovir or placebo gel. Participants will receive 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 will receive ongoing condom counseling and free condoms.
To assess the safety of tenofovir gel for vaginal use in HIV-uninfected women versus a placebo gel.
To assess the acceptability of and adherence to, two regimens of tenofovir gel in women.
To assess participant study burden.
Exploratory Objectives
To measure vaginal flora characteristics, and to descriptively examine changes in these characteristics over the course of prolonged tenofovir vaginal gel use
To assess the effects of tenofovir gel on cytokine and chemokine expression in cervical secretions
To evaluate the association between cytokine and chemokine expression
To correlate cytokine expression with colposcopic evidence of inflammation, epithelial disruption and genital symptoms