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IPERGAY

Status
Completed
Phase
III
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
Randomized
Double-blind
Arms and Assigned Interventions
Description
2 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 Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
2 tablets of placebo within 24 hours before first sexual relations, then 1 tablet of placebo every 24 hours during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of placebo approximatively 24 hours later
Mode of Delivery
Tablet
ARMs
Placebo Comparator
Trial Sponsors
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS), the Canadian Trial network, Bill and Melinda Gates Foundation, Fondation Pierre Bergé, Gilead Sciences
February 2012
June 2016
Enrollment
1 900
18
Years
Population
MSM
Sites

CHUM - Hôpital Hôtel Dieu

Montréal, Canada
Canada

Hôpital de La Croix Rousse

Lyon
France

CHU Hôtel Dieu

Nantes
France

Hôpital de l'Archet

Nice
France

Hôpital Tenon

Paris
France

Hôpital Saint-Louis

Paris
France

Hôpital Gustave Dron

Tourcoing
France