Longer-Acting Cabotegravir and Rilpivirine Injections for People Living With HIV
Compares two injectable HIV treatments in adults and adolescents whose virus is suppressed.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- San Juan, Puerto RicoSee the site
- Phase
- Phase 3
Where in Puerto Rico
- San JuanSan Juan, Puerto RicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ViiV Healthcare
- Trial code
- NCT07650916EU 2024-518511-19-00
- Record updated
- 10 November 2026
- Original description
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).Read full original descriptionShow less
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART
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: 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: 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; 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.