Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1%
Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900
young women at risk of sexually transmitted HIV infection. Participants will be provided with
a supply of single-use, pre-filled applicators according to their randomisation. While in the
study, participants will be asked to apply a first dose of the assigned study gel within 12
hours prior to coitus and insert a second dose as soon as possible within 12 hours after
coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic
treatment of sexually transmitted infections, if required.
Phase:
Phase 2
Details
Lead Sponsor:
Centre for the AIDS Programme of Research in South Africa
Collaborators:
CONRAD FHI 360 United States Agency for International Development (USAID)