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HPTN 047
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.
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HPTN 047 papers
published!
The HPTN study paper was
published in the February 20, 2006 issue of
AIDS Research and Therapy.
The study
concluded that 0.5% PRO 2000 Gel appeared to be safe when used twice-daily by
sexually active HIV-uninfected women from Pune, India. An ongoing Phase II/IIb
trial (HPTN 035)
would provide data for generalization of this finding.
Please find the reference
for the paper below.
Click on the title to view the
full text version on the
AIDS Research and Therapy
website.
Joshi S, Dutta S, Bell B,
Profy A, Kuruc J, Gai F, Cianciola M, Soto-Torres L, Panchanadikar A, Risbud A,
Mehendale S, Reynolds SJ, the HIV Prevention Trials 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 Research and Therapy. 2006 Feb 20; 3:4.
A follow-up paper on
acceptability of the HPTN 047 study product, PRO 2000 vaginal gel, was published
in the July 1, 2007 issue of AIDS Care. The reference for the paper
is below. Click on the title to view the paper's abstract and full-text
accessibility options.
Joglekar N, Joshi S,
Kakde M, et al.
Acceptability of PRO2000 vaginal gel among HIV un-infected women in Pune, India.
AIDS Care. 2007 Jul 01;19(6): 817-21.
Protocol Status:
Concluded
Study
Summary
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.
SDMC Protocol Specialist:
Missy Cianciola
get info
Protocol Co-Chair:
Steven J. Reynolds
get info
Protocol Chair:
Smita Joshi
get info
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