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).

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.

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf.

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

This is an open-label study.