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NCT07202546PHASE2Recruiting

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

ViiV Healthcare

Start Date

2/11/2026

Completion Date

5/22/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. 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. 2. Screening CD4+ T-cell count \>200 cells/microlitre (µL). 3. 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. 4. Treatment-naive: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection. 5. 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). 6. There are no contraceptive requirements for participants assigned male at birth. 7. 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. 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. Exclusion Criteria: 1. Participants who are breastfeeding or plan to breastfeed during the study. 2. 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. 3. Any evidence of an active Centres for Disease Control and Prevention (CDC) Stage 3 disease \[CDC 2014\], except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells/µL are not exclusionary. 4. 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). 5. History of cirrhosis with or without viral hepatitis co-infection. 6. Participants with HCV co-infection will be excluded from the study. 7. 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. 8. Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor. 9. 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. 10. 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 11. 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. 12. Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication. 13. 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. 14. 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. 15. Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant. 16. 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. 17. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. 18. Exposure to an approved vaccine within 14 days prior to Day 1. 19. Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research 20. Participants with known or suspected presence of virologic resistance mutations as defined by the Stanford HIV Drug Resistance Database to INSTIs or NRTIs. This determination will be based on local virologic resistance testing, either at Screening or within the 3 months prior to Screening. ViiV Healthcare clinical virologist and/or ViiV Healthcare medical monitor will verify eligibility to this criterion prior to Day 1. 21. Creatinine clearance (eGFR) of \<60 mL/min/1.73 m2 via CKD-EPI race neutral method \[Delgado, 2021\]. 22. ALT \>3 times the upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility. 23. Any Grade 4 laboratory abnormality at screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility. 24. Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. 25. Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination and will be the screening ECG entered into the eCRF): QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 msec (males) or \>470 msec (females); \>480 msec for participants with bundle branch block.

Interventions

DRUG

VH4524184

DRUG

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

DRUG

Dolutegravir / Lamivudine (DTG/3TC)

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Conditions

HIV Infections

Locations

GSK Investigational Site

Bakersfield, California 93301

United States

GSK Investigational Site

Palm Springs, California 92262

United States

GSK Investigational Site

West Hollywood, California 90046

United States

GSK Investigational Site

Aurora, Colorado 80045

United States

GSK Investigational Site

New Haven, Connecticut 06501

United States

GSK Investigational Site

Ft. Pierce, Florida 34982

United States

GSK Investigational Site

Hollywood, Florida 33021

United States

GSK Investigational Site

Miami, Florida 33136

United States

GSK Investigational Site

Miami Gardens, Florida 33055

United States

GSK Investigational Site

Oakland Park, Florida 33334

United States

GSK Investigational Site

Orlando, Florida 32803

United States

GSK Investigational Site

Orlando, Florida 32803

United States

GSK Investigational Site

West Palm Beach, Florida 33409

United States

GSK Investigational Site

Atlanta, Georgia 30308

United States

GSK Investigational Site

Macon, Georgia 31201

United States

GSK Investigational Site

Chicago, Illinois 60637

United States

GSK Investigational Site

Louisville, Kentucky 40202

United States

GSK Investigational Site

Columbia, Missouri 65212

United States

GSK Investigational Site

Kansas City, Missouri 64111

United States

GSK Investigational Site

Omaha, Nebraska 68106

United States

GSK Investigational Site

Hackensack, New Jersey 07601

United States

GSK Investigational Site

Newark, New Jersey 07102

United States

GSK Investigational Site

Albany, New York 12208

United States

GSK Investigational Site

Manhasset, New York 11030

United States

GSK Investigational Site

Charlotte, North Carolina 28204

United States

GSK Investigational Site

Durham, North Carolina 27710

United States

GSK Investigational Site

Greensboro, North Carolina 27401

United States

GSK Investigational Site

Wilmington, North Carolina 28401

United States

GSK Investigational Site

Cincinnati, Ohio 45267

United States

GSK Investigational Site

Bellaire, Texas 77401

United States

GSK Investigational Site

Dallas, Texas 75246

United States

GSK Investigational Site

Houston, Texas 77025

United States

GSK Investigational Site

Houston, Texas 77030

United States

GSK Investigational Site

Longview, Texas 75605

United States

GSK Investigational Site

Seattle, Washington 98104

United States

GSK Investigational Site

Buenos Aires, 1023

Argentina

GSK Investigational Site

Buenos Aires, 1427

Argentina

GSK Investigational Site

Buenos Aires, C1425AGC

Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1002ABJ

Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, 1405

Argentina

GSK Investigational Site

Mar del Plata, B7600FZO

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000IHE

Argentina

GSK Investigational Site

Sydney, New South Wales 2010

Australia

GSK Investigational Site

Clayton, Victoria 3168

Australia

GSK Investigational Site

Melbourne, Victoria 3004

Australia

GSK Investigational Site

Antwerp, 2000

Belgium

GSK Investigational Site

Brussels, 1000

Belgium

GSK Investigational Site

Ghent, 9000

Belgium

GSK Investigational Site

Montreal, Quebec H2L 4P9

Canada

GSK Investigational Site

Montreal, Quebec H4A 3J1

Canada

GSK Investigational Site

Bordeaux, 33000

France

GSK Investigational Site

Caen, 14033

France

GSK Investigational Site

Nantes, 44093

France

GSK Investigational Site

Nîmes, 30029

France

GSK Investigational Site

Paris, 75012

France

GSK Investigational Site

Paris, 75013

France

GSK Investigational Site

Berlin, 10787

Germany

GSK Investigational Site

Cologne, 50937

Germany

GSK Investigational Site

Frankfurt, 60590

Germany

GSK Investigational Site

Hamburg, 20146

Germany

GSK Investigational Site

München, 80337

Germany

GSK Investigational Site

Bergamo, 24127

Italy

GSK Investigational Site

Milan, 20122

Italy

GSK Investigational Site

Milan, 20127

Italy

GSK Investigational Site

Milan, 20142

Italy

GSK Investigational Site

Milan, 20157

Italy

GSK Investigational Site

Roma, 00149

Italy

GSK Investigational Site

Roma,

Italy

GSK Investigational Site

Fukuoka, 810-8563

Japan

GSK Investigational Site

Kanagawa, 221-0855

Japan

GSK Investigational Site

Okinawa, 901-2725

Japan

GSK Investigational Site

Osaka, 534-0021

Japan

GSK Investigational Site

Osaka, 540-0006

Japan

GSK Investigational Site

Tokyo, 108-8639

Japan

GSK Investigational Site

Tokyo, 160-0023

Japan

GSK Investigational Site

Tokyo, 162-8655

Japan

GSK Investigational Site

Bydgoszcz, 85-030

Poland

GSK Investigational Site

Gdansk, 80-405

Poland

GSK Investigational Site

Porto, 4099-001

Portugal

GSK Investigational Site

Porto, 4200-319

Portugal

GSK Investigational Site

Vila Nova de Gaia, 4434-502

Portugal

GSK Investigational Site

Daegu, 700-721

South Korea

GSK Investigational Site

Gwangju, 61469

South Korea

GSK Investigational Site

Pusan, 49241

South Korea

GSK Investigational Site

Seoul, 03722

South Korea

GSK Investigational Site

A Coruña, 15006

Spain

GSK Investigational Site

Alicante, 03010

Spain

GSK Investigational Site

Almería, 04009

Spain

GSK Investigational Site

Badalona, 08916

Spain

GSK Investigational Site

Barcelona, 08003

Spain

GSK Investigational Site

Barcelona, 08036

Spain

GSK Investigational Site

Barcelona, 08041

Spain

GSK Investigational Site

Barcelona, 08097

Spain

GSK Investigational Site

Barcelona, 08830

Spain

GSK Investigational Site

Elche Alicante, 03203

Spain

GSK Investigational Site

Getafe, 28905

Spain

GSK Investigational Site

Granada, 18014

Spain

GSK Investigational Site

HebrOn, 08035

Spain

GSK Investigational Site

Madrid, 28006

Spain

GSK Investigational Site

Madrid, 28007

Spain

GSK Investigational Site

Madrid, 28020

Spain

GSK Investigational Site

Madrid, 28031

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28041

Spain

GSK Investigational Site

Madrid, 28046

Spain

GSK Investigational Site

Marbella, 29603

Spain

GSK Investigational Site

Málaga, 29010

Spain

GSK Investigational Site

Murcia, 30003

Spain

GSK Investigational Site

Palma de Mallorca, 07120

Spain

GSK Investigational Site

Palma de Mallorca, 07198

Spain

GSK Investigational Site

Sabadell Barcelona, 08208

Spain

GSK Investigational Site

Santa Cruz de Tenerife, 38320

Spain

GSK Investigational Site

Santander, 39011

Spain

GSK Investigational Site

Seville, 41013

Spain

GSK Investigational Site

Seville, 41014

Spain

GSK Investigational Site

Valencia, 46014

Spain

GSK Investigational Site

Valencia, 46026

Spain

GSK Investigational Site

Vigo Pontevedra, 36312

Spain

GSK Investigational Site

Zaragoza, 50009

Spain

GSK Investigational Site

Kaohsiung City, 807

Taiwan

GSK Investigational Site

Kaohsiung City, 813

Taiwan

GSK Investigational Site

Taipei, 11217

Taiwan

GSK Investigational Site

Taoyuan, 330

Taiwan