RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

Sponsor: Gilead Sciences • ClinicalTrials.gov ID: NCT07708727

Registry updated: 2026-10-13

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

GS-3242 Tablet (Drug)
Administered orally
GS-3242 Injection (Drug)
Administered intramuscularly (IM)
Lenacapavir Tablet (Drug)
Administered orally
Lenacapavir Injection (Drug)
Administered IM
B/F/TAF (Drug)
Administered orally

Eligibility criteria

Key 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. Key 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.

Conditions

HIV-1-infection

Locations

Lundquist Inst Biomedical Innovation Harbor-UCLA — Torrance, California, United States
Yale University; School of Medicine; AIDS Program — New Haven, Connecticut, United States
Midway Immunology and Research Center — Ft. Pierce, Florida, United States
Orlando Immunology Center, PA — Orlando, Florida, United States
Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
Emory University Hospital Midtown Infectious Disease Clinic — Atlanta, Georgia, United States
Metro Infectious Disease Consultants, P.L.L.C — Decatur, Georgia, United States
KC care Health Center — Kansas City, Missouri, United States
St Hope Foundation, Inc, — Bellaire, Texas, United States
Prism Health North Texas — Dallas, Texas, United States
North Texas Infectious Diseases Consultants, PA — Dallas, Texas, United States
Texas Centers for Infectious Disease Associates — Fort Worth, Texas, United States
McGill University Health Centre — Decarie Montreal, Canada
CHU de Québec-Université Laval — Québec, Canada
Proyecto ACTU — Rio Piedras, PR, Puerto Rico
HOPE Clinical Research — San Juan, PR, Puerto Rico

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment