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

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

Aug 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

• Gilead Clinical Study Information Center
  1-833-445-3230 (GILEAD-0)
  [email protected]

Locations (45)

Find similar trials in Phoenix, AZ

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