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

Purpose

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.

Condition

  • HIV-1-infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel Assignment (Part A randomized parallel groups; Part B (conditional) single-arm, non-randomized)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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 up to 52 weeks.
  • Drug: GS-3242 Tablet
    Administered orally
  • Drug: GS-3242 Injection
    Administered intramuscularly (IM)
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • LEN
  • Drug: Lenacapavir Injection
    Administered IM
    Other names:
    • LEN
Experimental
Part A: Group 2 of GS-3242 + LEN 		Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.
  • Drug: GS-3242 Tablet
    Administered orally
  • Drug: GS-3242 Injection
    Administered intramuscularly (IM)
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • LEN
  • Drug: Lenacapavir Injection
    Administered IM
    Other names:
    • LEN
Experimental
Part A: Group 3 of B/F/TAF 		Participants will be randomized to continue to receive 50/200/25 mg of B/F/TAF daily for up to 52 weeks.
  • Drug: B/F/TAF
    Administered orally
Experimental
Part B: Group 4 (Conditional) 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 injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.
  • Drug: GS-3242 Tablet
    Administered orally
  • Drug: GS-3242 Injection
    Administered intramuscularly (IM)
  • Drug: Lenacapavir Tablet
    Administered orally
    Other names:
    • LEN
  • Drug: Lenacapavir Injection
    Administered IM
    Other names:
    • LEN

Recruiting Locations

Midway Immunology and Research Center
Ft. Pierce, Florida 34982

North Texas Infectious Disease Consultants, P.A.
Dallas, Texas 75246

Diagnostic Clinic of Longview
Longview, Texas 75605

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com