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NCT07650916PHASE3Recruiting

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

ViiV Healthcare

Start Date

6/25/2026

Completion Date

9/4/2029

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 Criteria

Age Range: 12 years to No maximum

Inclusion criteria: Patient Study Participant (PSP) Inclusion criteria: * Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \>35 kg. * Documented HIV-1 RNA measurements \<50 copies/mL in the 12 months prior to Screening. * HIV-1 RNA \<50 copies/mL at screening assessment. * Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening. * Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL). Exclusion criteria: Patient Study Participant (PSP) Exclusion criteria: * Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening. * Any history of receiving long-acting therapy for HIV. * Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection. * Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

CAB ULA

DRUG

RPV ULA

DRUG

CAB LA

DRUG

RPV LA

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Conditions

HIV Infections

Locations

GSK Investigational Site

Phoenix, Arizona 85015

United States

GSK Investigational Site

Bakersfield, California 93309

United States

GSK Investigational Site

Los Angeles, California 90027

United States

GSK Investigational Site

Los Angeles, California 90036

United States

GSK Investigational Site

San Diego, California 92103

United States

GSK Investigational Site

West Hollywood, California 90046

United States

GSK Investigational Site

New Haven, Connecticut 06510

United States

GSK Investigational Site

Washington D.C., District of Columbia 20017

United States

GSK Investigational Site

DeLand, Florida 32720

United States

GSK Investigational Site

Fort Lauderdale, Florida 33316

United States

GSK Investigational Site

Ft. Pierce, Florida 34982-7148

United States

GSK Investigational Site

Jacksonville, Florida 32209

United States

GSK Investigational Site

Miami, Florida 33136

United States

GSK Investigational Site

Orlando, Florida 32803-1851

United States

GSK Investigational Site

Pensacola, Florida 32503

United States

GSK Investigational Site

Vero Beach, Florida 32960-6541

United States

GSK Investigational Site

West Palm Beach, Florida 33407

United States

GSK Investigational Site

West Palm Beach, Florida 33409

United States

GSK Investigational Site

Decatur, Georgia 30033

United States

GSK Investigational Site

Baltimore, Maryland 21287

United States

GSK Investigational Site

Grosse Pointe Woods, Michigan 48236

United States

GSK Investigational Site

Kansas City, Missouri 64111

United States

GSK Investigational Site

Las Vegas, Nevada 89101

United States

GSK Investigational Site

Newark, New Jersey 07102-1909

United States

GSK Investigational Site

Santa Fe, New Mexico 87505

United States

GSK Investigational Site

Stony Brook, New York 11794

United States

GSK Investigational Site

Syracuse, New York 13057

United States

GSK Investigational Site

Greensboro, North Carolina 27401

United States

GSK Investigational Site

Winston-Salem, North Carolina 27157

United States

GSK Investigational Site

Columbus, Ohio 43210

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19104

United States

GSK Investigational Site

Pittsburgh, Pennsylvania 15212

United States

GSK Investigational Site

Austin, Texas 78705-3326

United States

GSK Investigational Site

Dallas, Texas 75219

United States

GSK Investigational Site

Dallas, Texas 75246-2004

United States

GSK Investigational Site

El Paso, Texas 79902

United States

GSK Investigational Site

Houston, Texas 77098

United States

GSK Investigational Site

Salt Lake City, Utah 84102

United States

GSK Investigational Site

Lynchburg, Virginia 24501

United States

GSK Investigational Site

Seattle, Washington 98104

United States

GSK Investigational Site

Seattle, Washington 98104

United States

GSK Investigational Site

Buenos Aires, 1427

Argentina

GSK Investigational Site

Buenos Aires, C1023AAB

Argentina

GSK Investigational Site

Buenos Aires, C1181ACH

Argentina

GSK Investigational Site

Buenos Aires, C1425AGC

Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1405CKC

Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1425AWK

Argentina

GSK Investigational Site

Córdoba, X5000JJS

Argentina

GSK Investigational Site

Rosario, 2000

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000IHE

Argentina

GSK Investigational Site

Darlinghurst, New South Wales 2010

Australia

GSK Investigational Site

Sydney, New South Wales 2010

Australia

GSK Investigational Site

Taringa, Queensland 4068

Australia

GSK Investigational Site

Perth, Western Australia 6000

Australia

GSK Investigational Site

Curitiba, 80060-900

Brazil

GSK Investigational Site

Nova Iguaçu, 26030-380

Brazil

GSK Investigational Site

Rio de Janeiro, 21045900

Brazil

GSK Investigational Site

Salvador, 40110-060

Brazil

GSK Investigational Site

São Paulo, 04037-030

Brazil

GSK Investigational Site

São Paulo, 04121-000

Brazil

GSK Investigational Site

Vancouver, British Columbia V6Z 2T1

Canada

GSK Investigational Site

Ottawa, Ontario K1Y 4E9

Canada

GSK Investigational Site

Toronto, Ontario M5G 1K2

Canada

GSK Investigational Site

Montreal, Quebec H2L 4E9

Canada

GSK Investigational Site

Montreal, Quebec H2L 4P9

Canada

GSK Investigational Site

Montreal, Quebec H4A 3J1

Canada

GSK Investigational Site

Québec, Quebec G1R 2J6

Canada

GSK Investigational Site

Regina, Saskatchewan S4P 0W5

Canada

GSK Investigational Site

Aichi, 460-0001

Japan

GSK Investigational Site

Kanagawa, 221-0855

Japan

GSK Investigational Site

Osaka, 540-0006

Japan

GSK Investigational Site

Tokyo, 108-8639

Japan

GSK Investigational Site

Tokyo, 113-8677

Japan

GSK Investigational Site

Tokyo, 162-8655

Japan

GSK Investigational Site

San Pedro Garza García, Nuevo León 66260

Mexico

GSK Investigational Site

Guadajalara, 44280

Mexico

GSK Investigational Site

Mexico City, 06760

Mexico

GSK Investigational Site

Mexico City, 14080

Mexico

GSK Investigational Site

Mérida, 97070

Mexico

GSK Investigational Site

San Juan, 00909

Puerto Rico

GSK Investigational Site

Pozuelo de Alarcón, Madrid 28224

Spain

GSK Investigational Site

Alicante, 03010

Spain

GSK Investigational Site

Badalona, 08005

Spain

GSK Investigational Site

Barcelona, 08026

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Barcelona, 08036

Spain

GSK Investigational Site

Barcelona, 8907

Spain

GSK Investigational Site

Burgos, 09006

Spain

GSK Investigational Site

Cartagena Murcia, 30202

Spain

GSK Investigational Site

Córdoba, 14004

Spain

GSK Investigational Site

Elche Alicante, 03203

Spain

GSK Investigational Site

Madrid, 28007

Spain

GSK Investigational Site

Madrid, 28031

Spain

GSK Investigational Site

Madrid, 28034

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28041

Spain

GSK Investigational Site

Madrid, 28046

Spain

GSK Investigational Site

Sabadell Barcelona, 08208

Spain

GSK Investigational Site

Seville, Sevilla

Spain

GSK Investigational Site

Valencia, 46014

Spain

GSK Investigational Site

Vigo Pontevedra, 36312

Spain

GSK Investigational Site

Birmingham, West Midlands B9 5SS

United Kingdom

GSK Investigational Site

Liverpool, L7 8YE

United Kingdom

GSK Investigational Site

London, E1 1FR

United Kingdom

GSK Investigational Site

London, SE1 7EH

United Kingdom

GSK Investigational Site

London, SW10 9NH

United Kingdom

GSK Investigational Site

London, W2 1NY

United Kingdom

GSK Investigational Site

London, WC1E 6JB

United Kingdom