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A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
NCT07202546 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG VH4524184
- DRUG Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets
- DRUG Dolutegravir / Lamivudine (DTG/3TC)
Study Locations (20)
Florida
- GSK Investigational Site — Ft. Pierce
- GSK Investigational Site — Miami
- GSK Investigational Site — Miami Gardens
- GSK Investigational Site — Oakland Park
- GSK Investigational Site — Orlando
- GSK Investigational Site — Orlando
- GSK Investigational Site — West Palm Beach
California
- GSK Investigational Site — Bakersfield
- GSK Investigational Site — Palm Springs
- GSK Investigational Site — West Hollywood
Georgia
- GSK Investigational Site — Atlanta
- GSK Investigational Site — Macon
Missouri
- GSK Investigational Site — Columbia
- GSK Investigational Site — Kansas City
North Carolina
- GSK Investigational Site — Greensboro
- GSK Investigational Site — Wilmington
Texas
- GSK Investigational Site — Bellaire
- GSK Investigational Site — Longview
Nebraska
- GSK Investigational Site — Omaha
New Jersey
- GSK Investigational Site — Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2026-02-11 |
| Est. Completion | 2028-09-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07202546
The ClinicalTrials.gov registry entry for NCT07202546 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions — of which VH4524184 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07202546 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07202546 about?
NCT07202546 is a clinical study titled "A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)". 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/...
What is the current status of trial NCT07202546?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2026-02-11. Estimated completion is 2028-09-22.
What conditions does trial NCT07202546 study?
This clinical trial studies the following conditions: HIV Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07202546?
The interventions under investigation include: VH4524184 (DRUG), Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets (DRUG), Dolutegravir / Lamivudine (DTG/3TC) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07202546?
This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07202546 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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