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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
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
Conditions
Interventions
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
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Charlotte, North Carolina, United States
GSK Investigational Site
Greensboro, North Carolina, United States
GSK Investigational Site
Wilmington, North Carolina, United States
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Akron, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Innsbruck, Austria
GSK Investigational Site
Vienna, Austria
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Brussels, Belgium
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Ghent, Belgium
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Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
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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
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Modena, Italy
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Roma, Italy
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Torino, Italy
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Mérida, Mexico
GSK Investigational Site
Monterrey, Mexico
GSK Investigational Site
Amsterdam, Netherlands
GSK Investigational Site
Rotterdam, Netherlands
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Utrecht, Netherlands
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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