Partners PrEP OLE
Status:Completed
Phase:Open Label
Principal Investigator(s):Jared Baeten, Renee Heffron
Objective:In July 2011, the Partners PrEP independent DSMB recommended public report of results and discontinuation of placebo arm. The active arms continued and the placebo arm was re-randomized to PrEP to collect additional comparative data on safety and efficacy.
** Results upon OLE completion in December 2012 showed both TDF and TDF/FTC highly efficacious (85% estimated efficacy of TDF & 93% of FTC/TDF).**
Prevention Option(s):PrEP
Study Design:Open label
Arms and Assigned Interventions
Description
Mode of Delivery
ARMs
Trial Sponsors:
Bill & Melinda Gates Foundation, NIH, USAID
Start Date
End Date
July 1, 2011
December 31, 2012
Enrollment:4,591
Age range:
↔
any
Population: