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ACTIVE NOT RECRUITING
NCT05911360
PHASE3

A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

Summary

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

Official title: A Phase 3b, Multicenter, Single-arm, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to DTG/3TC Single Tablet Regimen Administered Once Daily From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in People Living With HIV of at Least 50 Years of Age Who Are Virologically Suppressed

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

205

Start Date

2023-01-31

Completion Date

2026-01-13

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

DRUG

DTG/3TC

DTG/3TC FDC will be administered once daily.

Locations (56)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Palm Springs, California, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Ft. Pierce, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

Decatur, Georgia, United States

GSK Investigational Site

Macon, Georgia, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Berkley, Michigan, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

The Bronx, New York, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Wilmington, North Carolina, United States

GSK Investigational Site

Akron, Ohio, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Innsbruck, Austria

GSK Investigational Site

Vienna, Austria

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Nice, France

GSK Investigational Site

Orléans, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Freiburg im Breisgau, Germany

GSK Investigational Site

Hanover, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Modena, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Torino, Italy

GSK Investigational Site

Mérida, Mexico

GSK Investigational Site

Monterrey, Mexico

GSK Investigational Site

Amsterdam, Netherlands

GSK Investigational Site

Rotterdam, Netherlands

GSK Investigational Site

Utrecht, Netherlands

GSK Investigational Site

Porto, Portugal

GSK Investigational Site

Porto, Portugal

GSK Investigational Site

Vila Nova de Gaia, Portugal

GSK Investigational Site

Guadalajara, Spain

GSK Investigational Site

Manresa Barcelona, Spain

GSK Investigational Site

Sabadell Barcelona, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Liverpool, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom