RecruitingPhase 3NCT07650916

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

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


Sponsor

ViiV Healthcare

Enrollment

564 participants

Start Date

Jun 25, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CAB LA, a drug called CAB ULA, and others for people with hiv infections. The study is currently recruiting participants at 54 locations. People eligible for this study include aged 12 Years and older.

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

DRUGCAB ULA

CAB ULA will be administered.

DRUGRPV ULA

RPV ULA will be administered.

DRUGCAB LA

CAB LA will be administered.

DRUGRPV LA

RPV LA will be administered.


Locations(54)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

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

GSK Investigational Site

DeLand, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Ft. Pierce, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Pensacola, Florida, United States

GSK Investigational Site

Vero Beach, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Decatur, Georgia, United States

GSK Investigational Site

Grosse Pointe Woods, Michigan, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Newark, New Jersey, United States

GSK Investigational Site

Santa Fe, New Mexico, United States

GSK Investigational Site

Stony Brook, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

El Paso, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Lynchburg, Virginia, United States

GSK Investigational Site

Seattle, Washington, 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 Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Darlinghurst, New South Wales, Australia

GSK Investigational Site

Sydney, New South Wales, Australia

GSK Investigational Site

Taringa, Queensland, Australia

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT07650916


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