Recruiting
Phase 3

CAB ULA vs. RPV ULA

Sponsor:

ViiV Healthcare

Code:

NCT07650916

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

CAB ULA

RPV ULA

CAB LA

RPV LA

Study Details

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

Study ID

NCT07650916

Start date

Jun 25, 2026

Status verified date

Aug, 2026

Completion date

Sep 4, 2029

Anticipated

Primary completion date

Sep 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

564 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CAB ULA+ RPV ULA

Participants will receive CAB ULA+RPV ULA.

active comparator: CAB LA+ RPV LA

Participants will receive CAB LA+RPV LA.

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.

Primary outcome measure

  • 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 [ Time Frame: At Month 11 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

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

Locations

GSK Investigational Site

Recruiting

Phoenix, Arizona, United States, 85015

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Douglas Cunningham

GSK Investigational Site

Recruiting

Bakersfield, California, United States, 93301

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Franco Felizarta

GSK Investigational Site

Recruiting

Los Angeles, California, United States, 90027

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

William Towner

GSK Investigational Site

Recruiting

Los Angeles, California, United States, 90036

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Peter Ruane

GSK Investigational Site

Recruiting

San Diego, California, United States, 92103

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Timothy Wilkin

GSK Investigational Site

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Onyema Ogbuagu

GSK Investigational Site

Recruiting

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

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Theo Hodge

GSK Investigational Site

Recruiting

DeLand, Florida, United States, 32720

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Godson Oguchi

GSK Investigational Site

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Michael Sension

GSK Investigational Site

Recruiting

Ft. Pierce, Florida, United States, 34982

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Moti Ramgopal

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33136

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Charles Mitchell

GSK Investigational Site

Recruiting

Orlando, Florida, United States, 32803

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Charlotte-Paige Rolle

GSK Investigational Site

Recruiting

Pensacola, Florida, United States, 32503

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mitchell Whitehead

GSK Investigational Site

Recruiting

Vero Beach, Florida, United States, 32960

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Gerald Pierone

GSK Investigational Site

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Olayemi Osiyemi

GSK Investigational Site

Recruiting

West Palm Beach, Florida, United States, 33409

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Hector Bolivar

GSK Investigational Site

Recruiting

Decatur, Georgia, United States, 30033

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Alexandra Dretler

GSK Investigational Site

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Leonard Johnson

GSK Investigational Site

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Blair Thedinger

GSK Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89101

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jerry Cade

GSK Investigational Site

Recruiting

Newark, New Jersey, United States, 07102

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jihad Slim

GSK Investigational Site

Recruiting

Santa Fe, New Mexico, United States, 87505

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Joel Gallant

GSK Investigational Site

Recruiting

Stony Brook, New York, United States, 11794

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sharon Nachman

GSK Investigational Site

Recruiting

Syracuse, New York, United States, 13057

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Elizabeth Asiago-Reddy

GSK Investigational Site

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Cornelius Van Dam

GSK Investigational Site

Recruiting

Columbus, Ohio, United States, 43210

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jose Bazan

GSK Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

William Short

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78705

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Cynthia Brinson

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75219

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Marc Tribble

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75246

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Christopher Bettacchi

GSK Investigational Site

Recruiting

El Paso, Texas, United States, 79902

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ogechika Alozie

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77098

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Gordon Crofoot, Jr., MD

GSK Investigational Site

Recruiting

Salt Lake City, Utah, United States, 84102

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Harry Rosado-Santos

GSK Investigational Site

Recruiting

Lynchburg, Virginia, United States, 24501

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Joseph Saabiye

GSK Investigational Site

Recruiting

Seattle, Washington, United States, 98104

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Peter Shalit

GSK Investigational Site

Recruiting

Vancouver, British Columbia, Canada, V6Z 2T1

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Malcolm Hedgcock

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 1K2

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mona Loutfy

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H2L 4E9

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Elise Sasseville

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H2L 4P9

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jason Szabo

More Information

Sponsor

ViiV Healthcare

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by ViiV Healthcare on 2026-08-14.