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Phase 2b Study for HIV-1 Treatment (INNOVATE Study)

This study is testing a new oral medication, VH4524184, for adults with HIV-1 who have not yet received treatment. We are comparing two different doses of VH4524184, each taken with emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The main goal is to see how many participants achieve a very low level of HIV-1 in their blood (plasma HIV-1 RNA suppression) after 12 months. To join, you must be at least 18 years old, have a CD4+ T-cell count above 200, and a documented HIV-1 infection with a viral load of at least 1000 copies/mL. The study aims to enroll 186 participants.

Study design
This is an interventional Phase 2b study comparing different oral drug regimens for HIV-1. It plans to enroll 186 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Month 12, indicating follow-up for at least one year.

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NCT07202546

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
ViiV Healthcare
~186 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:VH4524184Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tabletsDolutegravir / Lamivudine (DTG/3TC)

At a glance

Recruiting sites
123 of 123 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Suppression (<50 copies/millilitre) as per FDA Snapshot Methodology
Measured over At Month 12

Conditions

HIV Infections

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HIV Infection

Where it's being run

123 sites across 29 states
Spain34
Florida8
Japan8
Argentina7
Italy7
France6
Texas5
Germany5

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
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Eligibility criteria

Inclusion

Is a Participant of non-childbearing potential (PONCBP);OR Is a Participant of childbearing potential (POCBP) and using a contraceptive method with a failure rate of less than (\<) 1% prior to and during the study intervention period, and for at least 1 week after the last dose of VH4524184 plus FTC/TAF FDC, or through the end of study (if in the control arm and never received VH4524184).
A POCBP must have a negative pregnancy test at Screening (serum) and on Day 1 (urine) before the first dose of study intervention.
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. Participant with a positive serum test must be excluded. 8. Capable of giving signed informed consent. Persons who are placed in an institution by order of a public authority or a court are excluded from participation in this study.

What this trial measures

  • Percentage of Participants Achieving Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Suppression (<50 copies/millilitre) as per FDA Snapshot MethodologyAt Month 12