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A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed
Sponsor: ViiV Healthcare
Summary
This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).
Official title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
564
Start Date
2026-06-25
Completion Date
2029-09-04
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
Interventions
CAB ULA
CAB ULA will be administered.
RPV ULA
RPV ULA will be administered.
CAB LA
CAB LA will be administered.
RPV LA
RPV LA will be administered.
Locations (88)
GSK Investigational Site
Phoenix, Arizona, United States
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Bakersfield, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Ft. Pierce, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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West Palm Beach, Florida, United States
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Decatur, Georgia, United States
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Grosse Pointe Woods, Michigan, United States
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Kansas City, Missouri, United States
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Las Vegas, Nevada, United States
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Newark, New Jersey, United States
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Santa Fe, New Mexico, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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Greensboro, North Carolina, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Lynchburg, Virginia, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Ciudad Autonoma Buenos Aires, Argentina
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Ciudad Autonoma Buenos Aires, Argentina
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Córdoba, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Darlinghurst, New South Wales, Australia
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Sydney, New South Wales, Australia
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Taringa, Queensland, Australia
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Aichi, Japan
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Kanagawa, Japan
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Osaka, Japan
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Tokyo, Japan
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Tokyo, Japan
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Tokyo, Japan
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San Pedro Garza García, Nuevo León, Mexico
GSK Investigational Site
Guadajalara, Mexico
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Mexico City, Mexico
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Mexico City, Mexico
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Mérida, Mexico
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San Juan, Puerto Rico
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Alicante, Spain
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Badalona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Burgos, Spain
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Cartagena Murcia, Spain
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Córdoba, Spain
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Elche Alicante, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
GSK Investigational Site
Madrid, Spain
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Sabadell Barcelona, Spain
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Seville, Spain
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Valencia, Spain
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Vigo Pontevedra, Spain
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Birmingham, United Kingdom
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London, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom