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

NCT07708727 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GS-US-643-65572026-526026-40
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (19)

• Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA Snapshot Algorithm

  Week 12

• Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm

  Week 52

• Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12

  Baseline, Week 12

• Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35

  Baseline, Week 35

• Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52

  Baseline, Week 52

Study Arms (6)

Phase 2: Part A: Group 1 of GS-3242 + LEN

EXPERIMENTAL

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.

Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Phase 2: Part A: Group 2 of GS-3242 + LEN

EXPERIMENTAL

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.

Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Phase 2: Part A: Group 3 of B/F/TAF

EXPERIMENTAL

Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks.

Drug: B/F/TAF

Phase 2: Part B: Group 4 of GS-3242 + LEN

EXPERIMENTAL

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.

Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Phase 3: Group 1 of GS-3242 + LEN

EXPERIMENTAL

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.

Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Phase 3: Group 2 of B/F/TAF

EXPERIMENTAL

Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks.

Drug: B/F/TAF

Interventions

GS-3242 Tablet DRUG

Administered orally

Phase 2: Part A: Group 1 of GS-3242 + LEN; Phase 2: Part A: Group 2 of GS-3242 + LEN; Phase 2: Part B: Group 4 of GS-3242 + LEN; Phase 3: Group 1 of GS-3242 + LEN

GS-3242 Injection DRUG

Administered intramuscularly (IM)

Phase 2: Part A: Group 1 of GS-3242 + LEN; Phase 2: Part A: Group 2 of GS-3242 + LEN; Phase 2: Part B: Group 4 of GS-3242 + LEN; Phase 3: Group 1 of GS-3242 + LEN

Lenacapavir Tablet DRUG

Administered orally

Also known as: LEN

Phase 2: Part A: Group 1 of GS-3242 + LEN; Phase 2: Part A: Group 2 of GS-3242 + LEN; Phase 2: Part B: Group 4 of GS-3242 + LEN; Phase 3: Group 1 of GS-3242 + LEN

Lenacapavir Injection DRUG

Administered IM

Also known as: LEN

Phase 2: Part A: Group 1 of GS-3242 + LEN; Phase 2: Part A: Group 2 of GS-3242 + LEN; Phase 2: Part B: Group 4 of GS-3242 + LEN; Phase 3: Group 1 of GS-3242 + LEN

B/F/TAF DRUG

Administered orally

Also known as: Biktarvy

Phase 2: Part A: Group 3 of B/F/TAF; Phase 3: Group 2 of B/F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

MeSH Terms

Interventions

lenacapavir; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): April 1, 2033
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share