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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

NCT07650916

RecruitingPhase 3

Sponsor: ViiV Healthcare

Conditions: HIV Infections

Interventions: CAB ULA, RPV ULA, CAB LA, RPV LA

Countries: United States, Argentina, Australia, Canada, Japan, Mexico, Puerto Rico, Spain

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).

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (88)

Phoenix, Arizona, United States
Bakersfield, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
West Palm Beach, Florida, United States
Decatur, Georgia, United States
Grosse Pointe Woods, Michigan, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Newark, New Jersey, United States
Santa Fe, New Mexico, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Greensboro, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
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