RecruitingPhase 2NCT07202546

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

A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of Oral VH4524184 Coadministered With Emtricitabine and Tenofovir Alafenamide in Treatment Naive Viremic Persons With HIV-1 (INNOVATE Study)


Sponsor

ViiV Healthcare

Enrollment

150 participants

Start Date

Feb 11, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral HIV treatment regimen called VH4524184 in people who have recently been diagnosed with HIV and have never taken antiretroviral (HIV) medication before. The goal is to see if this new once-daily pill can effectively suppress the virus. **You may be eligible if...** - You are 18 or older and have been diagnosed with HIV-1 - You have never taken HIV medication before - Your CD4 cell count is above 200, and your viral load is at least 1,000 copies/mL - Your weight and BMI fall within the required ranges - You are willing to use effective contraception if applicable **You may NOT be eligible if...** - You have ever taken antiretroviral (HIV) drugs before, even briefly - You are pregnant or breastfeeding - You have certain medical conditions or take medications that could interfere with the study drugs - Your organ function does not meet the study's requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVH4524184

Oral tablet will be administered.

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

Oral table will be administered.

DRUGDolutegravir / Lamivudine (DTG/3TC)

Oral tablets will be administered.


Locations(62)

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Palm Springs, California, United States

GSK Investigational Site

West Hollywood, California, United States

GSK Investigational Site

Ft. Pierce, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami Gardens, Florida, United States

GSK Investigational Site

Oakland Park, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Macon, Georgia, United States

GSK Investigational Site

Columbia, Missouri, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Newark, New Jersey, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Bellaire, Texas, United States

GSK Investigational Site

Longview, Texas, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Okinawa, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

A Coruña, Spain

GSK Investigational Site

Alicante, Spain

GSK Investigational Site

Badalona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Elche Alicante, Spain

GSK Investigational Site

Getafe, Spain

GSK Investigational Site

Granada, Spain

GSK Investigational Site

HebrOn, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Marbella, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Murcia, Spain

GSK Investigational Site

Palma de Mallorca, Spain

GSK Investigational Site

Palma de Mallorca, Spain

GSK Investigational Site

Sabadell Barcelona, Spain

GSK Investigational Site

Santa Cruz de Tenerife, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Vigo Pontevedra, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Kaohsiung City, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07202546


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