A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
Start Date
6/15/2026
Completion Date
4/1/2033
Summary
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26. The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
GS-3242 Tablet
GS-3242 Injection
Lenacapavir Tablet
Lenacapavir Injection
B/F/TAF
Conditions
Locations
Midway Immunology and Research Center
Ft. Pierce, Florida 34982
United States
North Texas Infectious Disease Consultants, P.A.
Dallas, Texas 75246
United States
Diagnostic Clinic of Longview
Longview, Texas 75605
United States