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Partners PrEP

Status
Completed
Phase
III
Principal Investigator(s)
Connie Celum
Objective

Demonstrate if PrEP decreases HIV-1 acquisition among HIV uninfected individuals within HIV-1 discordant couples. 

Prevention Option(s)
PrEP
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily
Mode of Delivery
Tablet
Products
TDF
ARMs
Experimental
Description
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily
ARMs
Experimental
Trial Sponsors
Bill and Melinda Gates Foundation, University of Washington
May 2008
October 2010
Enrollment
4 758
18
Years
65
Years
Population
Women
Men
Serodiscordant
Sites

Moi University - Indiana University

Eldoret
Kenya

CMR, Kemri-UCSF

Kisumu
Kenya

Kenyatta National Hospital/University of Nairobi

Nairobi
Kenya

Partners in Prevention - Thika

Thika
Kenya

Kabwohe Clinical Research Center

Bushenyi
Uganda

Infectious Diseases Institute

Jinja
Uganda

Partners House-Infectious Disease Institute Ltd

Kampala
Uganda

The AIDS Support Organization (TASO)

Mbale
Uganda

The AIDS Support Organization - Tororo Field Station

Tororo
Uganda