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DISCOVER

Status
Ongoing
Phase
III
Principal Investigator(s)
Scott McCallister, MD
Objective

The primary objective of this study is to assess the rates of HIV-1 seroconversion in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir DF (F/TDF) with a minimum follow-up of 48 weeks and at least 50 percent of participants have 96 weeks of follow-up. Learn more from our DISCOVER Trial Factsheet.


Preliminary Results: CROI Mar. 6, 2019-- In a multinational population of cis-MSM and TGW at risk of sexual HIV infection, the HIV incidence rate on either F/TAF or F/TDF was very low and significantly less than the background rate in those at risk but not on PrEP in the US. In almost 2 years of follow up, both F/TAF and F/TDF, given daily, were tolerated and had low discontinuation rates. 

Prevention Option(s)
PrEP
Study Design
Double-blind
Arms and Assigned Interventions
Description
F/TAF+ F/TDF placebo for at least 96 weeks
Mode of Delivery
Tablet
Products
F/TAF
ARMs
Experimental
Description
F/TDF+ F/TAF placebo for at least 96 weeks
Mode of Delivery
Tablet
Products
F/TDF
ARMs
Experimental
Description
Once all participants have been on blinded treatment for at least 96 weeks, the study will be unblinded and participants will be offered the option to continue on open-label F/TAF treatment in the open-label extension.
Mode of Delivery
Tablet
Products
F/TAF
ARMs
Experimental
Trial Sponsors
Gilead
August 2016
July 2021
Enrollment
5 400
18
Years
Population
MSM
Sites

Site(s) - United States

United States of America

Site(s)-Austria

Austria

Site(s)- United Kingdom

United Kingdom

Site(s)-Denmark

Denmark

Site(s)-Italy

Italy

Site(s)-Spain

Spain

Site(s)-Ireland

Ireland

Site(s)-Germany

Germany

Site(s)- Canada

Canada

Site(s)- Netherlands

Netherlands