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NCT Number: NCT07708727

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

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.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GS-3242 Tablet

Drug

Administered orally

GS-3242 Injection

Drug

Administered intramuscularly (IM)

Lenacapavir Tablet

Drug

Administered orally

Other names: LEN

Lenacapavir Injection

Drug

Administered IM

Other names: LEN

B/F/TAF

Drug

Administered orally

Other names: Biktarvy

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

    Time frame: Week 12

  2. 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

    Time frame: Week 52

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 35

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

    Time frame: Baseline, Week 52

  6. Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26

    Time frame: Baseline, Week 26

  7. Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12

    Time frame: From first dose date up to Week 12

  8. Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35

    Time frame: Week 35

  9. Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26

    Time frame: From first dose date up to Week 26

  10. Phase 2: Parts A and B and Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

    Time frame: From first dose date up to Week 52

  11. Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 18

    Time frame: Week 18

  12. Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35

    Time frame: Week 35

  13. Phase 2: Part A and Part B: Trough Concentrations of GS-3242 and LEN at Week 52

    Time frame: Week 52

  14. Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26

    Time frame: Week 26

  15. Phase 3: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm

    Time frame: Week 104

  16. Phase 3: Change From Baseline in CD4 Cell Count at Week 52

    Time frame: Baseline, Week 52

  17. Phase 3: Change From Baseline in CD4 Cell Count at Week 104

    Time frame: Baseline, Week 104

  18. Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

    Time frame: From first dose up to Week 52

  19. Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104

    Time frame: From first dose up to Week 104

Study contacts

Contact information is provided by the study sponsor or research team.

Gilead Clinical Study Information Center

CONTACT

[email protected]

1-833-445-3230 (GILEAD-0)

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2033
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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