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 · NCT07650916 · Interventional (participants receive a specific treatment) · Lead sponsor: ViiV Healthcare
View the official record on ClinicalTrials.gov →Interventions studied
CAB LACAB ULARPV LARPV ULA
What this trial 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 take part
Age range
12 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 19 US states.
- 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
- GSK Investigational Site - Pensacola, Florida, United States
- GSK Investigational Site - Vero Beach, Florida, United States
- GSK Investigational Site - West Palm Beach, Florida, United States
- GSK Investigational Site - West Palm Beach, Florida, United States
- GSK Investigational Site - Decatur, Georgia, United States
- GSK Investigational Site - Grosse Pointe Woods, Michigan, United States
- GSK Investigational Site - Kansas City, Missouri, United States
- GSK Investigational Site - Las Vegas, Nevada, United States
- GSK Investigational Site - Newark, New Jersey, United States
- GSK Investigational Site - Santa Fe, New Mexico, United States
- GSK Investigational Site - Stony Brook, New York, United States
- GSK Investigational Site - Syracuse, New York, United States
- GSK Investigational Site - Greensboro, North Carolina, United States
- GSK Investigational Site - Columbus, Ohio, United States
- GSK Investigational Site - Philadelphia, Pennsylvania, United States
- GSK Investigational Site - Austin, Texas, United States
- GSK Investigational Site - Dallas, Texas, United States
- GSK Investigational Site - Dallas, Texas, United States
- GSK Investigational Site - El Paso, Texas, United States
- GSK Investigational Site - Houston, Texas, United States
- GSK Investigational Site - Salt Lake City, Utah, United States
- GSK Investigational Site - Lynchburg, Virginia, United States
- GSK Investigational Site - Seattle, Washington, United States
- GSK Investigational Site - Aichi, Japan
- GSK Investigational Site - Alicante, Spain
- GSK Investigational Site - Badalona, Spain
- GSK Investigational Site - Barcelona, Spain
- GSK Investigational Site - Barcelona, Spain
- GSK Investigational Site - Barcelona, Spain
- GSK Investigational Site - Barcelona, Spain
- GSK Investigational Site - Birmingham, United Kingdom
- GSK Investigational Site - Buenos Aires, Argentina
- GSK Investigational Site - Buenos Aires, Argentina
- GSK Investigational Site - Buenos Aires, Argentina
- GSK Investigational Site - Burgos, Spain
- GSK Investigational Site - Cartagena Murcia, Spain
- GSK Investigational Site - Ciudad Autonoma Buenos Aires, Argentina
- GSK Investigational Site - Ciudad Autonoma Buenos Aires, Argentina
- GSK Investigational Site - Córdoba, Argentina
- GSK Investigational Site - Córdoba, Spain
- GSK Investigational Site - Elche Alicante, Spain
- GSK Investigational Site - Guadajalara, Mexico
- GSK Investigational Site - Kanagawa, Japan
- GSK Investigational Site - London, United Kingdom
- GSK Investigational Site - London, United Kingdom
- GSK Investigational Site - London, United Kingdom
- GSK Investigational Site - London, United Kingdom
- GSK Investigational Site - Madrid, Spain
Showing 60 of 88 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →