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.
Last updated September 30, 2021
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, Randomized
Arms and Assigned Interventions
DescriptionF/TAF+ F/TDF placebo for at least 96 weeks
Mode of DeliveryTablet
ARMsExperimental
DescriptionF/TDF+ F/TAF placebo for at least 96 weeks
Mode of DeliveryTablet
ARMsExperimental
DescriptionOnce 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 DeliveryTablet
ARMsExperimental
Official Code:
NCT02842086
Trial Sponsors:
Gilead
Start Date
End Date
September 2, 2016
September 1, 2021
Enrollment:5,399
Age range:
18 Years ↔
any
Population:Gay and Bisexual Men Who Have Sex with Men, Transgender Women