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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.
Last updated September 30, 2021
Prevention Option(s)
PrEP
Study Design
Randomized
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
Official Code
Trial Sponsors
Gilead Sciences
September 2016
September 2021
Date of Enrollment Completion
January 31, 2019
Enrollment
5 399
18
Years
Population
MSM
Transgender women
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