Microbicide Trials Network

HPTN 059

Details

Protocol Title: 
Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel
DAIDS Protocol ID: 
10145
Status: 
Concluded

Protocol Chair(s)

Sharon Hillier (Protocol Chair)
Craig Hoesley (Protocol Co-Chair)
Jessica Justman (Protocol Co-Chair)

Description

HPTN 059 is a four-arm, multi-center, randomized controlled Phase II (expanded safety) trial that aims to assess the safety and acceptability of an antiretroviral-based candidate microbicide called tenofovir topical gel (1 % tenofovir gel) used either daily or before each act of sex. HPTN 059 also seeks to determine how prolonged gel use over six months affects vaginal flora, the vagina’s naturally protective population of microorganisms, and whether the activity of certain immune system molecules called chemokines and cytokines can be useful measures for assessing the safety of microbicides. The study involves 200 HIV-negative women at three sites– one in India and two in the United States. Once enrolled, women are randomly assigned to one of four groups: tenofovir gel applied daily, tenofovir gel applied up to two hours before sex, placebo gel used daily, and placebo gel applied prior to sex. Because the tenofovir and placebo gels look the same, neither researchers nor participants know who has been assigned to use which gel during the six-month study period. Throughout the study, participants receive free condoms and HIV risk-reduction counseling as well as routine testing and treatment for sexually transmitted infections. The first participant was enrolled in August 2006 and the study was closed to accrual in April 2007. Follow-up is expected to be completed in October 2007 and results of the trial available in early 2008.

Other Study Info

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 on Drug Abuse
US National Institute of Mental Health
US National Institutes of Health

Co-Sponsored by:
Gilead Sciences, Inc.