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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 3

Age range

12 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

564 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 treatment or prevention of HIV
• Previous exposure to injectable CAB and/or injectable 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (111)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

111 locations

Study team and timeline

Lead sponsor

ViiV Healthcare

Study start

Jun 25, 2026 Actual

Primary completion

Aug 13, 2029 Estimated

Study completion

Aug 13, 2029 Estimated

First posted

Jun 16, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts