An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Treatment-Naive People With HIV-1

Date Added
December 30th, 2024
PRO Number
Pro00141056
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

The main objective of this study is to test a once-weekly HIV medication regimen in persons who have not taken HIV treatment before. The goal is to see if taking a once a week pill combination (GS-1720 and GS-4182) works as well as taking a daily pill Biktarvy® (B/F/TAF). Participants will either take the weekly pill or continue with Biktarvy® for about 48 weeks or longer. The study will look at how well each option controls HIV levels.

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

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Date Added
March 16th, 2023
PRO Number
Pro00125361
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

The primary objective of this study is to determine how bictegravir (BIC) plus lenacapvir (LEN) in two different doses affects an HIV-1 infection in the body compared with current standard treatment regimens. Other objectives are to determine which of these treatments are the most effective for treating HIV-1 infection, the safety and tolerability of these two doses for people with HIV, as well as how long it stays in the body using physical exams, laboratory tests, ECG, blood analysis, and any symptoms or problems experienced during the study.

Institution
MUSC
Recruitment Contact
Marion Campbell
843-792-8894
cammario@musc.edu



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