Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Date Added
June 5th, 2024
PRO Number
Pro00136188
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

This study is for adults with HIV who are currently being treated with Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF]). The purpose of the research is to compare the effectiveness of B/F/TAF and the investigational once-daily medication Bictegravir/Lenacapavir (BIC/LEN). Participants will either continue taking B/F/TAF or switch to BIC/LEN for at least 48 weeks. The study will also look at the long-term effectiveness of BIC/LEN. Participants will be given the option of participating in an open-label phase of the study (where both the provider and participant know which drug they are on) where all participants receive BIC/LEN.

Institution
MUSC
Recruitment Contact
Jamila Williams
(843) 792-1088
keithja@musc.edu