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

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.