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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
Products
TDF/FTC (Truvada)
Results
Open Label Extension studies: Findings from Partners PrEP Study
Similar Trials
Partners PrEP
Partners Demonstration Project
Trial Sponsors
Bill & Melinda Gates Foundation; NIH; USAID
Product Developers
Gilead
July 2011
December 2012
Enrollment
4 591
Sites

Site(s) - Kenya

Kenya

Site(s) - Uganda

Uganda