On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
Status:
Completed
Trial end date:
2016-12-15
Target enrollment:
Participant gender:
Summary
This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel
groups is 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 (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B
virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV
infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed
recent studies have reported a higher incidence of new HIV infection in MSM as compared to
the general population, new approaches to the prevention of HIV infection are, therefore,
necessary in order to consider the limits of current strategies.
Phase:
Phase 3
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir