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

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

Sponsor
Gilead Sciences
Study ID
NCT07645287
Phase
PHASE2
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 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.

Key Dates

First listed
Jun 12, 2026
Start date
Jun 15, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Apr 30, 2033

Study Design

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

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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 (3)

FacilityCityStateZIPSite coordinators
Midway Immunology and Research CenterFt. PierceFlorida34982-
North Texas Infectious Disease Consultants, P.A.DallasTexas75246-
Diagnostic Clinic of LongviewLongviewTexas75605-

Find similar trials in Ft. Pierce, FL

By research site
Midway Immunology and Research Center· Ft. Pierce, FLNorth Texas Infectious Disease Consultants, P.A.· Dallas, TXDiagnostic Clinic of Longview· Longview, TX

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