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

NCT07202546 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2226382025-521918-26-00
• Study Type: interventional
• Target: 150
• Locations: 13 countries
• Sites: 113

Brief 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

HIV Infections

Keywords

Fixed dose combination; Antiretroviral; Antiviral; Naive viremics; Innovate; VH4524184

Outcome Measures

Primary Outcomes (1)

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

  At Month 12

Secondary Outcomes (7)

• Percentage of Participants Maintaining Plasma HIV-1 RNA Suppression (<50 copies/mL) Based on Observed Laboratory Results

  Day 1 to Month 24

• Percentage of Participants Achieving Plasma HIV-1 RNA Suppression (<50 copies/ml) as per FDA Snapshot Methodology

  Day 1 to Month 24

• Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts

  Day 1 to Month 24

• Number of Participants with Any Adverse Event (AE)

  Day 1 to Month 24

• Number of Participants with AEs by Severity

  Day 1 to Month 24

Study Arms (4)

VH4524184 Dose A+ FTC / TAF

EXPERIMENTAL

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.

Drug: VH4524184; Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets

VH4524184 Dose B + FTC / TAF

EXPERIMENTAL

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.

Drug: VH4524184; Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets

DTG + 3TC

ACTIVE COMPARATOR

Participants receive a daily oral dose of DTG and 3TC (fixed dose combination) from Day 1 through Month 24.

Drug: Dolutegravir / Lamivudine (DTG/3TC)

VH4524184 selected dose + FTC / TAF

EXPERIMENTAL

Participants receive a selected dose of VH4524184, combined with FTC/TAF, orally once daily from to Month 12 to Month 24.

Drug: VH4524184; Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets

Interventions

VH4524184 DRUG

Oral tablet will be administered.

VH4524184 Dose A+ FTC / TAF; VH4524184 Dose B + FTC / TAF; VH4524184 selected dose + FTC / TAF

Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets DRUG

Oral table will be administered.

Also known as: DESCOVY

VH4524184 Dose A+ FTC / TAF; VH4524184 Dose B + FTC / TAF; VH4524184 selected dose + FTC / TAF

Dolutegravir / Lamivudine (DTG/3TC) DRUG

Oral tablets will be administered.

Also known as: DOVATO

DTG + 3TC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent.
• Screening CD4+ T-cell count \>200 cells/microlitre (µL).
• Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies/millilitre (mL). A single repeat of this test is allowed within a single Screening period to determine eligibility.
• Treatment-naive: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
• Body weight \>=50.0 kilogram (kg) \[(110 pounds (lbs)\] for participants assigned male at birth and \>=45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg/m\^2 (inclusive - applies to males and females).
• There are no contraceptive requirements for participants assigned male at birth.
• Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding and one of the following conditions applies:
• 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.
• Capable of giving signed informed consent.

You may not qualify if:

• Participants who are breastfeeding or plan to breastfeed during the study.
• Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
• Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
• History of cirrhosis with or without viral hepatitis co-infection.
• Participants with HCV co-infection will be excluded from the study.
• Individuals who are co-infected with HIV and HBV will be excluded Participants diagnosed with syphilis at Screening (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to enroll at any time regardless of the stage of disease.
• Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor.
• Any pre-existing physical, or mental condition (including alcohol or drug abuse) which, in the opinion of the investigator (with or without psychiatric evaluation) or the ViiV Healthcare medical monitor, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
• Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, that may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication and normal gastrointestinal anatomy or motility or hepatic and/or renal function
• Clinically significant CV disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
• Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
• History of sensitivity to any of the study medications, or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or ViiV Healthcare medical monitor, contraindicates their participation.
• Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
• Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
• Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of Day 1.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (113)

GSK Investigational Site

Bakersfield, California, 93301, United States

RECRUITING

GSK Investigational Site

Palm Springs, California, 92262, United States

RECRUITING

GSK Investigational Site

West Hollywood, California, 90046, United States

RECRUITING

GSK Investigational Site

Aurora, Colorado, 80045, United States

RECRUITING

GSK Investigational Site

New Haven, Connecticut, 06501, United States

RECRUITING

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

RECRUITING

GSK Investigational Site

Hollywood, Florida, 33021, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33136, United States

RECRUITING

GSK Investigational Site

Miami Gardens, Florida, 33055, United States

RECRUITING

GSK Investigational Site

Oakland Park, Florida, 33334, United States

RECRUITING

GSK Investigational Site

Orlando, Florida, 32803, United States

RECRUITING

GSK Investigational Site

Orlando, Florida, 32803, United States

RECRUITING

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

RECRUITING

GSK Investigational Site

Atlanta, Georgia, 30308, United States

RECRUITING

GSK Investigational Site

Macon, Georgia, 31201, United States

RECRUITING

GSK Investigational Site

Louisville, Kentucky, 40202, United States

RECRUITING

GSK Investigational Site

Columbia, Missouri, 65212, United States

RECRUITING

GSK Investigational Site

Kansas City, Missouri, 64111, United States

RECRUITING

GSK Investigational Site

Omaha, Nebraska, 68106, United States

RECRUITING

GSK Investigational Site

Newark, New Jersey, 07102, United States

RECRUITING

GSK Investigational Site

Albany, New York, 12208, United States

RECRUITING

GSK Investigational Site

Manhasset, New York, 11030, United States

RECRUITING

GSK Investigational Site

Charlotte, North Carolina, 28204, United States

RECRUITING

GSK Investigational Site

Greensboro, North Carolina, 27401, United States

RECRUITING

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

RECRUITING

GSK Investigational Site

Cincinnati, Ohio, 45267, United States

RECRUITING

GSK Investigational Site

Bellaire, Texas, 77401, United States

RECRUITING

GSK Investigational Site

Dallas, Texas, 75246, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77025, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77030, United States

RECRUITING

GSK Investigational Site

Longview, Texas, 75605, United States

RECRUITING

GSK Investigational Site

Seattle, Washington, 98104, United States

RECRUITING

GSK Investigational Site

Buenos Aires, 1023, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, 1427, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1425AGC, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1002ABJ, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Bueno, 1405, Argentina

RECRUITING

GSK Investigational Site

Mar del Plata, B7600FZO, Argentina

RECRUITING

GSK Investigational Site

San Miguel de Tucumán, T4000IHE, Argentina

RECRUITING

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

RECRUITING

GSK Investigational Site

Clayton, Victoria, 3168, Australia

RECRUITING

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

RECRUITING

GSK Investigational Site

Antwerp, 2000, Belgium

RECRUITING

GSK Investigational Site

Brussels, 1000, Belgium

RECRUITING

GSK Investigational Site

Ghent, 9000, Belgium

RECRUITING

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

GSK Investigational Site

Nantes, 44093, France

RECRUITING

GSK Investigational Site

Nîmes, 30029, France

RECRUITING

GSK Investigational Site

Paris, 75012, France

RECRUITING

GSK Investigational Site

Berlin, 10787, Germany

RECRUITING

GSK Investigational Site

Cologne, 50937, Germany

RECRUITING

GSK Investigational Site

Frankfurt, 60590, Germany

RECRUITING

GSK Investigational Site

Hamburg, 20146, Germany

RECRUITING

GSK Investigational Site

München, 80337, Germany

RECRUITING

GSK Investigational Site

Bergamo, 24127, Italy

RECRUITING

GSK Investigational Site

Milan, 20122, Italy

RECRUITING

GSK Investigational Site

Milan, 20127, Italy

RECRUITING

GSK Investigational Site

Milan, 20142, Italy

RECRUITING

GSK Investigational Site

Milan, 20157, Italy

RECRUITING

GSK Investigational Site

Palermo, 90127, Italy

RECRUITING

GSK Investigational Site

Roma, 00149, Italy

RECRUITING

GSK Investigational Site

Roma, Italy

RECRUITING

GSK Investigational Site

Fukuoka, 810-8563, Japan

RECRUITING

GSK Investigational Site

Kanagawa, 221-0855, Japan

RECRUITING

GSK Investigational Site

Okinawa, 901-2725, Japan

RECRUITING

GSK Investigational Site

Osaka, 534-0021, Japan

RECRUITING

GSK Investigational Site

Osaka, 540-0006, Japan

RECRUITING

GSK Investigational Site

Tokyo, 160-0023, Japan

RECRUITING

GSK Investigational Site

Tokyo, 162-8655, Japan

RECRUITING

GSK Investigational Site

Bydgoszcz, 85-030, Poland

RECRUITING

GSK Investigational Site

Gdansk, 80-405, Poland

RECRUITING

GSK Investigational Site

Gaia, 4434-502, Portugal

RECRUITING

GSK Investigational Site

Porto, 4099-001, Portugal

RECRUITING

GSK Investigational Site

Porto, 4200-319, Portugal

RECRUITING

GSK Investigational Site

A Coruña, 15006, Spain

RECRUITING

GSK Investigational Site

Alicante, 03010, Spain

RECRUITING

GSK Investigational Site

Almeira, 04009, Spain

RECRUITING

GSK Investigational Site

Badalona, 08916, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08003, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08036, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08041, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08097, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08830, Spain

RECRUITING

GSK Investigational Site

Elche Alicante, 03203, Spain

RECRUITING

GSK Investigational Site

Getafe, 28905, Spain

RECRUITING

GSK Investigational Site

Granada, 18014, Spain

RECRUITING

GSK Investigational Site

HebrOn, 08035, Spain

RECRUITING

GSK Investigational Site

Madrid, 28006, Spain

RECRUITING

GSK Investigational Site

Madrid, 28007, Spain

RECRUITING

GSK Investigational Site

Madrid, 28020, Spain

RECRUITING

GSK Investigational Site

Madrid, 28031, Spain

RECRUITING

GSK Investigational Site

Madrid, 28040, Spain

RECRUITING

GSK Investigational Site

Madrid, 28041, Spain

RECRUITING

GSK Investigational Site

Madrid, 28046, Spain

RECRUITING

GSK Investigational Site

Marbella, 29603, Spain

RECRUITING

GSK Investigational Site

Málaga, 29010, Spain

RECRUITING

GSK Investigational Site

Murcia, 30003, Spain

RECRUITING

GSK Investigational Site

Palma de Mallorca, 07120, Spain

RECRUITING

GSK Investigational Site

Palma de Mallorca, 07198, Spain

RECRUITING

GSK Investigational Site

Sabadell Barcelona, 08208, Spain

RECRUITING

GSK Investigational Site

Santa Cruz de Tenerife, 38320, Spain

RECRUITING

GSK Investigational Site

Santander, 39011, Spain

RECRUITING

GSK Investigational Site

Seville, 41013, Spain

RECRUITING

GSK Investigational Site

Seville, 41014, Spain

RECRUITING

GSK Investigational Site

Valencia, 46014, Spain

RECRUITING

GSK Investigational Site

Valencia, 46026, Spain

RECRUITING

GSK Investigational Site

Vigo Pontevedra, 36312, Spain

RECRUITING

GSK Investigational Site

Zaragoza, 50009, Spain

RECRUITING

GSK Investigational Site

Kaohsiung City, 807, Taiwan

RECRUITING

GSK Investigational Site

Kaohsiung City, 813, Taiwan

RECRUITING

GSK Investigational Site

Taipei, 11217, Taiwan

RECRUITING

GSK Investigational Site

Taoyuan, 330, Taiwan

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine; Racivir; tenofovir alafenamide; Tablets; emtricitabine tenofovir alafenamide; dolutegravir; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dosage Forms; Pharmaceutical Preparations; Zalcitabine; Dideoxynucleosides

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 2, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): July 26, 2027
• Study Completion (Estimated): July 24, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

CA (2); ES (34); AU (3); BE (3); PT (3); TW (4); DE (5); US (32); PL (2); FR (3); IT (8); AR (7); JP (7)