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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorViiV Healthcare

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CAB ULA
  • RPV ULA
  • CAB LA
  • RPV LA

Treatment groups

564 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators