A Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P)
What is HPTN 047?
Topical microbicides are antimicrobial agents formulated for application to the surface of the vagina and/or rectum for the prevention of HIV transmission during sexual intercourse. This prevention strategy is urgently needed throughout the world because many individuals at high risk of transmitting or acquiring HIV infection cannot or will not use condoms with every act of sexual intercourse. Reasons for lack of effective condom use include power imbalances in relationships that result in the inability of the receptive partner to negotiate condom use, physical discomfort and decreased sexual pleasure.
HPTN 047 is a Phase I study of 0.5% PRO 2000/5 Gel (P) to that was conducted among 60 HIV-uninfected sexually active women in Pune, India. The male partners of these women also were also enrolled in the study. Half of the female participants were at low risk for HIV infection; the other half were at higher risk. 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. The primary objective of this study was 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.
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.
HPTN 047 Publications
Joshi S, Dutta S, Bell B, Profy A, Kuruc J, Fang G, Cianciola M, Maslankowski L, Soto-Torres L, Panchanadikar A, Mehendale S, Reynolds SJ. Documenting intermenstrual bleeding in a vaginal microbicide study: case reports and lessons learned. AIDS Res Hum Retroviruses. 2006, 22: 294-6
Smita J, Soma D, Beverly B, Albert P, JoAnn K, Fang G, Missy C, Lydia ST, Anjali P, Arun R, Sanjay M, Steven J R; HIV Prevention Trial Network HPTN 047 Protocol Team. Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India. AIDS Res Ther (Epub). 2006, 3: 4 PMCID: 1435917
Joglekar N, Joshi S, Kakde M, Fang G, Cianciola M, Reynolds S, Mehendale S; HIV Prevention Trial Network 047 Protocol Team. Acceptability of PRO2000 vaginal gel among HIV un-infected women in Pune, India. AIDS Care. 2007, 19: 817-21 PMID: 17573603