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
- Montreal, Ottawa, Québec, Regina, Toronto, and Vancouver, CanadaSee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 or older who live with HIV-1 and whose virus is well controlled by daily pills. It compares two long-acting injection treatments.
- Age
- 12 years or older
- Sex
- All sexes
- Disease stage
- HIV-1 infection with virus well controlled: HIV-1 RNA <50 copies/mL at screening and in the 12 months before.
- Earlier treatment
- Must have taken the same daily oral HIV pills without a break for at least 6 months. Any earlier switch of treatment must not have been because the treatment failed (HIV-1 RNA ≥200 copies/mL).
- Biomarker or test result
- HIV-1 RNA <50 copies/mL at screening and in the 12 months before screening. Weight above 35 kg (77 lb).
Main reasons for not taking part
- Any known major resistance mutation to INSTI (including CAB) or NNRTI (including RPV) drugs
- Any past long-acting treatment or prevention for HIV
- Earlier injections of CAB or RPV for HIV treatment or prevention
- HIV immunotherapeutic vaccine within 90 days of screening
- Serious uncontrolled health problems (for example heart, liver, kidney, nerve or mental health) that could affect safety or taking part
Read by machine on 11 November 2026.
Where in Canada
- MontrealMontreal, CanadaTaking people
- OttawaOttawa, CanadaTaking people
- QuébecQuébec, CanadaTaking people
- ReginaRegina, CanadaTaking people
- TorontoToronto, CanadaTaking people
- VancouverVancouver, CanadaTaking 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.