Microbicide Trials Network

HPTN 035

Details

Protocol Title: 
Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention of HIV Infection in Women
DAIDS Protocol ID: 
10065
Status: 
Concluded

Protocol Chair(s)

Salim Abdool Karim (Protocol Chair)
Irving Hoffman (Protocol Co-Chair)
Lisa Maslankowski (Protocol Co-Chair)
Nancy Padian (Protocol Co-Chair)
Groesbeck Parham (Protocol Co-Chair)
Gita Ramjee (Protocol Co-Chair)
Taha Taha (Protocol Co-Chair)

Description

HPTN 035 is four-arm, multi-center Phase II/IIb randomized controlled trial that aims to determine the safety and effectiveness of two different candidate microbicides, BufferGel® and PRO 2000 (0.5% PRO 2000/5 Gel (P)) for the prevention of HIV in women. Participants are randomly assigned to one of four study groups: BufferGel, PRO 2000 gel, placebo gel, and no gel. Women assigned to the three gel groups apply gel up to one hour before sexual intercourse using pre-filled applicators. Because all three gels and applicators look the same, neither researchers nor participants know who has been assigned to use which gel for the duration of the study. Participants in all four groups receive free condoms, HIV risk reduction counseling, and routine testing and treatment for sexually transmitted infections. The study enrolled its first participant in February 2005. Accrual was completed in July 2007 at which time a total of 3,100 sexually active HIV-negative women had been enrolled at seven sites in Malawi, South Africa, Zambia, Zimbabwe, and the United States. Each study participant is followed for at least one year. Follow-up is expected to be completed in July 2008, and results of the study available in 2009.

Other Study Info

The University of Pennsylvania located in Philadelphia, Pennsylvania was also a site when the HPTN 035 study was active.

Sponsored by:
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institute on Drug Abuse
US National Institutes of Health 

Co-Sponsored by:
ReProtect, Inc.
Indevus Pharmaceuticals, Inc.