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RECRUITING
NCT07202546
PHASE2

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

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-02-11

Completion Date

2028-09-22

Last Updated

2026-03-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

VH4524184

Oral tablet will be administered.

DRUG

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

Oral table will be administered.

DRUG

Dolutegravir / 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