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

Part of paid clinical trials in Ft. Pierce, Florida.

Sponsor
Gilead Sciences
Study ID
NCT07708727
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GS-3242 Tablet — DRUG
    Administered orally
  • GS-3242 Injection — DRUG
    Administered intramuscularly (IM)
  • Lenacapavir Tablet — DRUG
    Administered orally
  • Lenacapavir Injection — DRUG
    Administered IM
  • B/F/TAF — DRUG
    Administered orally

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Jul 29, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2030
Completion
Apr 30, 2033

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Midway Immunology and Research CenterFt. PierceFlorida34982-
Triple O Research Institute, P.A.West Palm BeachFlorida33401-
Metro Infectious Disease Consultants, P.L.L.CDecaturGeorgia30033-
KC care Health CenterKansas CityMissouri64111-
St Hope Foundation, Inc,BellaireTexas77401-
North Texas Infectious Diseases Consultants, PADallasTexas75246-
Prism Health North TexasDallasTexas75208-

Find similar trials in Ft. Pierce, FL

By research site
Midway Immunology and Research Center· Ft. Pierce, FLTriple O Research Institute, P.A.· West Palm Beach, FLMetro Infectious Disease Consultants, P.L.L.C· Decatur, GAKC care Health Center· Kansas City, MOSt Hope Foundation, Inc· Bellaire, TXNorth Texas Infectious Diseases Consultants, PA· Dallas, TX

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