OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
July 2026 - October 2030
Study Type
Interventional
Study Phase
Phase 2, Phase 3
Product
GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection, B/F/TAF
Eligibility information
Inclusion criteria
- 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.
Exclusion criteria
- Prior usage of, or exposure to LEN or GS-3242
- Prior use of any long-acting parenteral ARV therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (16)
Lundquist Inst Biomedical Innovation Harbor-UCLA
Torrance, California, United States, 90502
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States, 06510
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
Orlando Immunology Center, PA
Orlando, Florida, United States, 32803
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33401
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States, 30308
Metro Infectious Disease Consultants, P.L.L.C
Decatur, Georgia, United States, 30033
KC care Health Center
Kansas City, Missouri, United States, 64111
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States, 75246
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States, 76109
McGill University Health Centre
Decarie Montreal, Canada, H4A 3J1
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