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

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT07650916

Run by

ViiV Healthcare

People needed

564

Starts

2026-06-25

Expected to finish

2029-09-04

Last updated by the study team

2026-08-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Bakersfield, California, United States (enrolling)
• GSK Investigational Site — Los Angeles, California, United States (enrolling)
• GSK Investigational Site — Los Angeles, California, United States (enrolling)
• GSK Investigational Site — San Diego, California, United States (enrolling)
• GSK Investigational Site — New Haven, Connecticut, United States (enrolling)
• GSK Investigational Site — Washington D.C., District of Columbia, United States (enrolling)
• GSK Investigational Site — DeLand, Florida, United States (enrolling)
• GSK Investigational Site — Fort Lauderdale, Florida, United States (enrolling)
• GSK Investigational Site — Ft. Pierce, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Orlando, Florida, United States (enrolling)
• GSK Investigational Site — Pensacola, Florida, United States (enrolling)
• GSK Investigational Site — Vero Beach, Florida, United States (enrolling)
• GSK Investigational Site — West Palm Beach, Florida, United States (enrolling)
• GSK Investigational Site — West Palm Beach, Florida, United States (enrolling)
• GSK Investigational Site — Decatur, Georgia, United States (enrolling)
• GSK Investigational Site — Grosse Pointe Woods, Michigan, United States (enrolling)
• GSK Investigational Site — Kansas City, Missouri, United States (enrolling)
• GSK Investigational Site — Las Vegas, Nevada, United States (enrolling)
• GSK Investigational Site — Newark, New Jersey, United States (enrolling)
• GSK Investigational Site — Santa Fe, New Mexico, United States (enrolling)
• GSK Investigational Site — Stony Brook, New York, United States (enrolling)
• GSK Investigational Site — Syracuse, New York, United States (enrolling)
• GSK Investigational Site — Greensboro, North Carolina, United States (enrolling)
• GSK Investigational Site — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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