Principal Investigator(s):Jean-Michel Molina, MD
Objective:Designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counseling, condoms, STD screening, HBV and HAV vaccinations and post-exposure treatment of HIV infection) in MSM, exposed to the risk of HIV infection. Randomization stopped in October 2014 after DSMB examination of data showed PrEP was protective against HIV. All trial participants offered PrEP “on demand.” Trial to continue for one year to demonstrate long-term benefit and safety of “on demand” PrEP. As of April 2016, follow-up is continuing.
Prevention Option(s):PrEP
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
Description2 tablets of truvada within 24 hours before first sexual relations, then 1 tablet of Truvada during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of Truvada approximately 24 hours later Other Name: tenofovir disoproxil and emtricitabine
Mode of DeliveryTablet
Official Code: NCT01473472
Trial Sponsors: Bill and Melinda Gates Foundation, Fondation Pierre Bergé, French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS), Gilead
Start Date
End Date
February 22, 2012
June 30, 2016
Age range: 18 Years ↔ any
Population:Gay and Bisexual Men Who Have Sex with Men