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

NCT07708727 · tracked via the Priya Life Science USA tracker

Sponsor

Gilead Sciences

Phase

Phase 2/3

Started

2026-07-29

Last updated

2026-09-09

Condition(s) studied

HIV-1-infection

Investigational drug(s) / intervention(s)

GS-3242 TabletGS-3242 InjectionLenacapavir TabletLenacapavir InjectionB/F/TAF

GS-3242 Tablet: Administered orally

GS-3242 Injection: Administered intramuscularly (IM)

Lenacapavir Tablet: Administered orally

Lenacapavir Injection: Administered IM

B/F/TAF: Administered orally

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Phase 2: Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm — Week 35
Phase 2: Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm — Week 26
Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm — Week 52

Trial sites (11)

Facility	City	Region	Status
Orlando Immunology Center, PA	Florida City	Florida	Recruiting
Midway Immunology and Research Center	Ft. Pierce	Florida	Recruiting
Triple O Research Institute, P.A.	West Palm Beach	Florida	Recruiting
Metro Infectious Disease Consultants, P.L.L.C	Decatur	Georgia	Recruiting
KC care Health Center	Kansas City	Missouri	Recruiting
St Hope Foundation, Inc,	Bellaire	Texas	Recruiting
Prism Health North Texas	Dallas	Texas	Recruiting
North Texas Infectious Diseases Consultants, PA	Dallas	Texas	Recruiting
Texas Centers for Infectious Disease Associates	Fort Worth	Texas	Recruiting
McGill University Health Centre	Montreal	Quebec	Recruiting
HOPE Clinical Research	San Juan	PR	Recruiting

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Other trials for the same condition

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children Recruiting

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance Active, not recruiting

Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101 Enrolling by invitation

Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed Active, not recruiting

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07708727 on ClinicalTrials.gov ↗ ← All trials in the USA