HPTN 047

A Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P)

Study Summary

What was HPTN 047?

A Phase I open-label study to assess the safety of repeated intravaginal doses of 0.5% PRO 2000/5 Gel (P) for 14 consecutive days between menses among sexually active HIV-uninfected women from Pune, India and to assess the acceptability of 0.5% PRO 2000/5 Gel (P) among sexually active HIV-uninfected women and men from Pune, India.

Who participated in the study?

60 HIV-uninfected women (30 low risk and 30 higher risk) and 60 HIV-uninfected male partners.

What happened during the study?

During the course of the study, both low and higher risk participants applied 0.5% PRO 2000/5 Gel (P) twice daily for 14 consecutive days between menses, and agree to have vaginal intercourse with a single male partner, using study-provided male condoms, at least twice per week during the two weeks of product application.

Results

Twenty-four participants (57%, 95% CI 41%-72%) experienced at least one adverse event (AE) judged to be possibly related to the product use.

Study Documents