A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)

Conditions

• HIV Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VH4524184 — DRUG
  Oral tablet will be administered.
• Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets — DRUG
  Oral table will be administered.
• Dolutegravir / Lamivudine (DTG/3TC) — DRUG
  Oral tablets will be administered.

Study Details

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Key Dates

Start date

Feb 11, 2026

Status verified

May 2026

Primary completion

Jul 26, 2027

Completion

Jul 24, 2028

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: VH4524184 Dose A+ FTC / TAF
  Participants receive a daily oral dose of VH4524184 Dose A (Low dose) in combination with a fixed dose containing FTC/TAF starting Day 1 until Month 12.
• Experimental: VH4524184 Dose B + FTC / TAF
  Participants receive a daily oral dose of VH4524184 Dose B (High dose) in combination with a fixed dose containing FTC / TAF beginning on Day 1 until the Month 12.
• Active Comparator: DTG + 3TC
  Participants receive a daily oral dose of DTG and 3TC (fixed dose combination) from Day 1 through Month 24.
• Experimental: VH4524184 selected dose + FTC / TAF
  Participants receive a selected dose of VH4524184, combined with FTC/TAF, orally once daily from to Month 12 to Month 24.

Primary Outcome Measure

Percentage of Participants Achieving Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Suppression (<50 copies/millilitre) as per FDA Snapshot Methodology [ Time Frame: At Month 12 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (32)

Find similar trials in Bakersfield, CA

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