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
Recruiting now Phase 3 NCT07650916
Run by ViiV Healthcare · for 12 and older · All sexes
What this study is about
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).
Who can join (things the study team will check)
✅ You may be able to join 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 be able to join 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
- 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
+ 42 more sites.
Who to contact
US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07650916.
Verify everything on the official ClinicalTrials.gov record. Page updated August 2026.
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