An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B. The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35. The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26. The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52. The primary objectives of this study are: Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26. Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening.
• Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening.
Locations
United States
Florida
Midway Immunology and Research Center
RECRUITING
Ft. Pierce
Triple O Research Institute, P.A.
RECRUITING
West Palm Beach
Georgia
Metro Infectious Disease Consultants, P.L.L.C
RECRUITING
Decatur
Missouri
KC care Health Center
RECRUITING
Kansas City
Texas
St Hope Foundation, Inc,
RECRUITING
Bellaire
North Texas Infectious Diseases Consultants, PA
RECRUITING
Dallas
Prism Health North Texas
RECRUITING
Dallas
Other Locations
Puerto Rico
HOPE Clinical Research
RECRUITING
San Juan
Contact Information
Primary
Gilead Clinical Study Information Center
leadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date:2026-07-29
Estimated Completion Date:2033-04
Participants
Target number of participants:700
Treatments
Experimental: Phase 2: Part A: Group 1 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN for at least 52 weeks.
Experimental: Phase 2: Part A: Group 2 of GS-3242 + LEN
Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks.
Experimental: Phase 2: Part A: Group 3 of B/F/TAF
Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks.
Experimental: Phase 2: Part B: Group 4 of GS-3242 + LEN
Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks.
Experimental: Phase 3: Group 1 of GS-3242 + LEN
Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 and LEN for at least 104 weeks.
Experimental: Phase 3: Group 2 of B/F/TAF
Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks.