Recruiting
Phase 2
Phase 3

GS-3242 & LEN

Sponsor:

Gilead Sciences

Code:

NCT07708727

Conditions

HIV-1-infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GS-3242 Tablet

GS-3242 Injection

Lenacapavir Tablet

Lenacapavir Injection

B/F/TAF

Study Details

Brief 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.

Conditions

HIV-1-infection

Study ID

NCT07708727

Start date

Jul 29, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2033

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

GS-3242 Tablet

Administered orally

GS-3242 Injection

Administered intramuscularly (IM)

Lenacapavir Tablet

Administered orally

Lenacapavir Injection

Administered IM

B/F/TAF

Administered orally

Primary outcome measure

  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)leadClinicalTrials@gilead.com

Locations

Midway Immunology and Research Center

Recruiting

Ft. Pierce, Florida, United States, 34982

Triple O Research Institute, P.A.

Recruiting

West Palm Beach, Florida, United States, 33401

Metro Infectious Disease Consultants, P.L.L.C

Recruiting

Decatur, Georgia, United States, 30033

KC care Health Center

Recruiting

Kansas City, Missouri, United States, 64111

St Hope Foundation, Inc,

Recruiting

Bellaire, Texas, United States, 77401

Prism Health North Texas

Recruiting

Dallas, Texas, United States, 75208

North Texas Infectious Diseases Consultants, PA

Recruiting

Dallas, Texas, United States, 75246

More Information

Sponsor

Gilead Sciences

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-08-14.