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
- HIV Infections
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- ViiV Healthcare
- Enrolment target
- 564
- Started
- 25 June 2026
- Main results due
- 4 September 2029
- Study sites
- 108
- Registry updated
- 28 September 2026
Can you take part?
- Aged 12 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(108)
GSK Investigational Site
Phoenix, Arizona, United States
Recruiting
GSK Investigational Site
Bakersfield, California, United States
Recruiting
GSK Investigational Site
Los Angeles, California, United States
Recruiting
GSK Investigational Site
Los Angeles, California, United States
Recruiting
GSK Investigational Site
San Diego, California, United States
Recruiting
GSK Investigational Site
West Hollywood, California, United States
Recruiting
GSK Investigational Site
New Haven, Connecticut, United States
Recruiting
GSK Investigational Site
Washington D.C., District of Columbia, United States
Recruiting
GSK Investigational Site
DeLand, Florida, United States
Recruiting
GSK Investigational Site
Fort Lauderdale, Florida, United States
Recruiting
GSK Investigational Site
Ft. Pierce, Florida, United States
Recruiting
GSK Investigational Site
Jacksonville, Florida, United States
Recruiting
GSK Investigational Site
Miami, Florida, United States
Recruiting
GSK Investigational Site
Orlando, Florida, United States
Recruiting
GSK Investigational Site
Pensacola, Florida, United States
Recruiting
GSK Investigational Site
Vero Beach, Florida, United States
Recruiting
GSK Investigational Site
West Palm Beach, Florida, United States
Recruiting
GSK Investigational Site
West Palm Beach, Florida, United States
Recruiting
GSK Investigational Site
Decatur, Georgia, United States
Recruiting
GSK Investigational Site
Baltimore, Maryland, United States
Recruiting
GSK Investigational Site
Grosse Pointe Woods, Michigan, United States
Recruiting
GSK Investigational Site
Kansas City, Missouri, United States
Recruiting
GSK Investigational Site
Las Vegas, Nevada, United States
Recruiting
GSK Investigational Site
Newark, New Jersey, United States
Recruiting
GSK Investigational Site
Santa Fe, New Mexico, United States
Recruiting
GSK Investigational Site
Stony Brook, New York, United States
Recruiting
GSK Investigational Site
Syracuse, New York, United States
Recruiting
GSK Investigational Site
Greensboro, North Carolina, United States
Recruiting
GSK Investigational Site
Winston-Salem, North Carolina, United States
Recruiting
GSK Investigational Site
Columbus, Ohio, United States
Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania, United States
Recruiting
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
Recruiting
GSK Investigational Site
Austin, Texas, United States
Recruiting
GSK Investigational Site
Dallas, Texas, United States
Recruiting
GSK Investigational Site
Dallas, Texas, United States
Recruiting
GSK Investigational Site
El Paso, Texas, United States
Recruiting
GSK Investigational Site
Houston, Texas, United States
Recruiting
GSK Investigational Site
Salt Lake City, Utah, United States
Recruiting
GSK Investigational Site
Lynchburg, Virginia, United States
Recruiting
GSK Investigational Site
Seattle, Washington, United States
Recruiting
GSK Investigational Site
Seattle, Washington, United States
Recruiting
GSK Investigational Site
Buenos Aires, Argentina
Recruiting
GSK Investigational Site
Buenos Aires, Argentina
Recruiting
GSK Investigational Site
Buenos Aires, Argentina
Recruiting
GSK Investigational Site
Buenos Aires, Argentina
Recruiting
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina
Recruiting
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina
Recruiting
GSK Investigational Site
Córdoba, Argentina
Recruiting
GSK Investigational Site
Rosario, Argentina
Recruiting
GSK Investigational Site
San Miguel de Tucumán, Argentina
Recruiting
GSK Investigational Site
Darlinghurst, New South Wales, Australia
Recruiting
GSK Investigational Site
Sydney, New South Wales, Australia
Recruiting
GSK Investigational Site
Taringa, Queensland, Australia
Recruiting
GSK Investigational Site
Perth, Western Australia, Australia
Recruiting
GSK Investigational Site
Curitiba, Brazil
Recruiting
GSK Investigational Site
Nova Iguaçu, Brazil
Recruiting
GSK Investigational Site
Rio de Janeiro, Brazil
Recruiting
GSK Investigational Site
Salvador, Brazil
Recruiting
GSK Investigational Site
São Paulo, Brazil
Recruiting
GSK Investigational Site
São Paulo, Brazil
Recruiting
Showing 60 of 108 sites — filter to narrow it down. 108 of the 108 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07650916. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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