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NCT Number: NCT07645287

A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.

The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

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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

Primary location

Midway Immunology and Research Center, Ft. Pierce, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL for ≥ 6 months before screening.
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.
  • Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening.
  • No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S).

Key Exclusion Criteria:

  • Prior use of, or exposure to GS-3242 or LEN.
  • History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.
  • Prior use of any long-acting parenteral antiretroviral 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

Primary outcomes

  1. 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. 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

Secondary outcomes

  1. Part A and Part 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

  2. Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the US FDA Snapshot Algorithm

    Time frame: Week 35

  3. Part A and Part 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

  4. Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35

    Time frame: Baseline, Week 35

  5. Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52

    Time frame: Baseline, Week 52

  6. 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

  7. Part B: Change From Baseline in CD4 Cell Count at Week 26

    Time frame: Baseline, Week 26

  8. Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35

    Time frame: Up to Week 35

  9. Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52

    Time frame: Up to Week 52

  10. Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26

    Time frame: Up to Week 26

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

    Time frame: Week 18

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

    Time frame: Week 35

  13. Part A: Group 1 and 2 and Part B: Groups 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 52

    Time frame: Week 52

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

    Time frame: Week 26

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

A Phase 2 Randomized, 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 Virologically Suppressed People With HIV-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2033
First posted
Jun 12, 2026
Registry last updated
Jul 10, 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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