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

NCT07650916 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2227942024-518511-19-00
• Study Type: interventional
• Target: 564
• Locations: 10 countries
• Sites: 108

Brief 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).

Conditions

HIV Infections

Keywords

Cabotegravir; Rilpivirine; HIV; Non-inferiority; Efficacy; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm

  At Month 11

Secondary Outcomes (12)

• Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm

  At Month 23

• Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm

  At Month 11 and Month 23

• Percentage of participants with confirmed virologic failure (CVF)

  Up to Month 23

• Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5

  Up to Month 23

• Number of participants with drug-related serious adverse events (SAEs)

  Up to Month 23

Study Arms (2)

CAB ULA+ RPV ULA

EXPERIMENTAL

Participants will receive CAB ULA+RPV ULA.

Drug: CAB ULA; Drug: RPV ULA

CAB LA+ RPV LA

ACTIVE COMPARATOR

Participants will receive CAB LA+RPV LA.

Drug: CAB LA; Drug: RPV LA

Interventions

CAB ULA DRUG

CAB ULA will be administered.

CAB ULA+ RPV ULA

RPV ULA DRUG

RPV ULA will be administered.

CAB ULA+ RPV ULA

CAB LA DRUG

CAB LA will be administered.

CAB LA+ RPV LA

RPV LA DRUG

RPV LA will be administered.

CAB LA+ RPV LA

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (108)

GSK Investigational Site

Phoenix, Arizona, 85015, United States

RECRUITING

GSK Investigational Site

Bakersfield, California, 93309, United States

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GSK Investigational Site

Los Angeles, California, 90027, United States

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GSK Investigational Site

Los Angeles, California, 90036, United States

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GSK Investigational Site

San Diego, California, 92103, United States

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GSK Investigational Site

West Hollywood, California, 90046, United States

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GSK Investigational Site

New Haven, Connecticut, 06510, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20017, United States

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GSK Investigational Site

DeLand, Florida, 32720, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

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GSK Investigational Site

Ft. Pierce, Florida, 34982-7148, United States

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GSK Investigational Site

Jacksonville, Florida, 32209, United States

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GSK Investigational Site

Miami, Florida, 33136, United States

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GSK Investigational Site

Orlando, Florida, 32803-1851, United States

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GSK Investigational Site

Pensacola, Florida, 32503, United States

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GSK Investigational Site

Vero Beach, Florida, 32960-6541, United States

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GSK Investigational Site

West Palm Beach, Florida, 33407, United States

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GSK Investigational Site

West Palm Beach, Florida, 33409, United States

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GSK Investigational Site

Decatur, Georgia, 30033, United States

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GSK Investigational Site

Baltimore, Maryland, 21287, United States

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GSK Investigational Site

Grosse Pointe Woods, Michigan, 48236, United States

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GSK Investigational Site

Kansas City, Missouri, 64111, United States

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GSK Investigational Site

Las Vegas, Nevada, 89101, United States

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GSK Investigational Site

Newark, New Jersey, 07102-1909, United States

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GSK Investigational Site

Santa Fe, New Mexico, 87505, United States

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GSK Investigational Site

Stony Brook, New York, 11794, United States

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GSK Investigational Site

Syracuse, New York, 13057, United States

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GSK Investigational Site

Greensboro, North Carolina, 27401, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27157, United States

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GSK Investigational Site

Columbus, Ohio, 43210, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15212, United States

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GSK Investigational Site

Austin, Texas, 78705-3326, United States

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GSK Investigational Site

Dallas, Texas, 75219, United States

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GSK Investigational Site

Dallas, Texas, 75246-2004, United States

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GSK Investigational Site

El Paso, Texas, 79902, United States

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GSK Investigational Site

Houston, Texas, 77098, United States

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GSK Investigational Site

Salt Lake City, Utah, 84102, United States

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GSK Investigational Site

Lynchburg, Virginia, 24501, United States

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GSK Investigational Site

Seattle, Washington, 98104, United States

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GSK Investigational Site

Seattle, Washington, 98104, United States

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GSK Investigational Site

Buenos Aires, 1427, Argentina

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GSK Investigational Site

Buenos Aires, C1023AAB, Argentina

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GSK Investigational Site

Buenos Aires, C1181ACH, Argentina

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GSK Investigational Site

Buenos Aires, C1425AGC, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1405CKC, Argentina

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GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1425AWK, Argentina

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GSK Investigational Site

Córdoba, X5000JJS, Argentina

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GSK Investigational Site

Rosario, 2000, Argentina

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GSK Investigational Site

San Miguel de Tucumán, T4000IHE, Argentina

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GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

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GSK Investigational Site

Sydney, New South Wales, 2010, Australia

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GSK Investigational Site

Taringa, Queensland, 4068, Australia

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GSK Investigational Site

Perth, Western Australia, 6000, Australia

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GSK Investigational Site

Curitiba, 80060-900, Brazil

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GSK Investigational Site

Nova Iguaçu, 26030-380, Brazil

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GSK Investigational Site

Rio de Janeiro, 21045900, Brazil

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GSK Investigational Site

Salvador, 40110-060, Brazil

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GSK Investigational Site

São Paulo, 04037-030, Brazil

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GSK Investigational Site

São Paulo, 04121-000, Brazil

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GSK Investigational Site

Vancouver, British Columbia, V6Z 2T1, Canada

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GSK Investigational Site

Ottawa, Ontario, K1Y 4E9, Canada

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GSK Investigational Site

Toronto, Ontario, M5G 1K2, Canada

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GSK Investigational Site

Montreal, Quebec, H2L 4E9, Canada

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GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

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GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

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GSK Investigational Site

Québec, Quebec, G1R 2J6, Canada

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GSK Investigational Site

Regina, Saskatchewan, S4P 0W5, Canada

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GSK Investigational Site

Aichi, 460-0001, Japan

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GSK Investigational Site

Kanagawa, 221-0855, Japan

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GSK Investigational Site

Osaka, 540-0006, Japan

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GSK Investigational Site

Tokyo, 108-8639, Japan

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GSK Investigational Site

Tokyo, 113-8677, Japan

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GSK Investigational Site

Tokyo, 162-8655, Japan

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GSK Investigational Site

San Pedro Garza García, Nuevo León, 66260, Mexico

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GSK Investigational Site

Guadajalara, 44280, Mexico

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GSK Investigational Site

Mexico City, 06760, Mexico

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GSK Investigational Site

Mexico City, 14080, Mexico

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GSK Investigational Site

Mérida, 97070, Mexico

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GSK Investigational Site

San Juan, 00909, Puerto Rico

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GSK Investigational Site

Pozuelo de Alarcón, Madrid, 28224, Spain

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GSK Investigational Site

Alicante, 03010, Spain

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GSK Investigational Site

Badalona, 08005, Spain

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GSK Investigational Site

Barcelona, 08026, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Barcelona, 8907, Spain

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GSK Investigational Site

Burgos, 09006, Spain

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GSK Investigational Site

Cartagena Murcia, 30202, Spain

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GSK Investigational Site

Córdoba, 14004, Spain

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GSK Investigational Site

Elche Alicante, 03203, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28031, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Sabadell Barcelona, 08208, Spain

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GSK Investigational Site

Seville, Sevilla, Spain

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GSK Investigational Site

Valencia, 46014, Spain

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GSK Investigational Site

Vigo Pontevedra, 36312, Spain

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GSK Investigational Site

Birmingham, West Midlands, B9 5SS, United Kingdom

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GSK Investigational Site

Liverpool, L7 8YE, United Kingdom

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GSK Investigational Site

London, E1 1FR, United Kingdom

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GSK Investigational Site

London, SE1 7EH, United Kingdom

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GSK Investigational Site

London, SW10 9NH, United Kingdom

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GSK Investigational Site

London, W2 1NY, United Kingdom

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GSK Investigational Site

London, WC1E 6JB, United Kingdom

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MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): September 4, 2029
• Study Completion (Estimated): September 4, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

AR (9); US (41); PR (1); GB (7); CA (8); AU (4); ES (21); ME (5); JP (6); BR (6)