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 was a Phase 2, multi-site, double-blind, controlled, randomized trial comparing the safety of intravaginal daily administration of tenofovir 1% gel or placebo gel to intravaginal coitally-dependent administration (i.e., prior to intercourse) of tenofovir 1% gel or placebo gel  during  24 weeks of product exposure and follow-up.  

 

The secondary objective was to assess the acceptability and adherence to tenofovir 1% gel for vaginal use in HIV-uninfected women versus placebo gel during 24 weeks of daily or coitally dependent use.  Adherence to the study gel regimen was assessed by an interviewer-administered questionnaire at weeks 4, 12 and 24. Summary measures of study gel and condom use over time were compared between study arms. Acceptability of the study gel was evaluated by an interviewer-administered questionnaire at enrollment (for vaginal product behavior assessment) and weeks 4, 12 and 24. Reasons for voluntary discontinuation and non-compliance related to study gel use were recorded and compared between study arms. Initial results were presented at the Microbicides 2008 Conference.

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.