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

Study Details

Protocol Status: Concluded
Study Purpose:

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; to assess the acceptability of 0.5% PRO 2000/5 Gel (P) among sexually active HIV-uninfected women and men from Pune, India.

Study Design:

Phase I open-label study with 14 days of twice daily application of 0.5% PRO 2000/5 Gel (P) and follow-up for each female participant. Safety will be assessed via pelvic exam with colposcopy; acceptability will be assessed via standardized questionnaires and focus groups.

Study Population:

HIV-uninfected sexually active women from Pune, India at low and higher risk for HIV infection; HIV-uninfected male partners of female participants.

Study Size:

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

Study Duration:

Accrual will require four months. Each participant female will be followed for 14 days of product use. Focus groups will be convened within approximately four weeks after the completion of product use and follow-up. Therefore the entire study should be completed within six months. December 2004 the HPTN SMC granted a 4 month extension for accrual due to slow enrollment. Study accrual extended until March 2004. Last participant enrolled completed follow-up on 05 April 2004.

Treatment Regimen:

Twice daily intravaginal application of 0.5% PRO 2000/5 Gel (P) for 14 consecutive days.

Primary Objectives:

To assess the safety of 0.5% PRO 2000/5 Gel (P) when administered twice daily for 14 consecutive days on the vulvar and cervicovaginal mucosa of sexually active HIV-uninfected women in Pune, India.

Secondary Objectives:

To assess the acceptability of, and adherence to, a short-term regimen of 0.5% PRO 2000 Gel among HIV-uninfected women in Pune, India.
To evaluate aspects of product acceptability among HIV-uninfected women and men in Pune, India.
To assess the feasibility of enrolling HIV-uninfected women at higher risk for HIV infection from Pune, India, into future Phase III vaginal microbicide trials.
To assess the effect of a twice daily short-term regimen of 0.5% PRO 2000/5 Gel (P) on the vaginal microflora of sexually active HIV-uninfected women in Pune, India.

Key Study Personnel

Missy Cianciola, SDMC Protocol Specialist
Smita N. Joshi, Protocol Chair
Steven J. Reynolds, Protocol Co-Chair