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
- Alicante, Badalona, Barcelona, Burgos, Cartagena, Córdoba, Elche, L'hospitalet De Llobregat, Madrid, Majadahonda, Sabadell, Sevilla, Valencia, and Vigo, SpainSee the 21 sites
- Phase
- Phase 3
Where in Spain
- Hospital General Universitario Dr. BalmisAlicante, SpainNo longer taking part
- Hospital Germans Trias i PujolBadalona, SpainNo longer taking part
- Hospital Clinic de BarcelonaBarcelona, SpainNo longer taking part
- Hospital de la Santa Creu i Sant PauBarcelona, SpainNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpainNo longer taking part
- Hospital Universitario De BurgosBurgos, SpainNo longer taking part
- Hospital General Universitario Santa LuciaCartagena, SpainNo longer taking part
- Hospital Universitario Reina SofiaCórdoba, SpainNo longer taking part
- Hospital General Universitario de ElcheElche, SpainNo longer taking part
- Bellvitge University HospitalL'hospitalet De Llobregat, SpainNo longer taking part
- Hospital Clínico San CarlosMadrid, SpainNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpainNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
- Hospital Universitario Infanta LeonorMadrid, SpainNo longer taking part
- Hospital Universitario La PazMadrid, SpainNo longer taking part
- Hospital Universitario Ramón y CajalMadrid, SpainNo longer taking part
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainNo longer taking part
- Parc Tauli Hospital UniversitariSabadell, SpainNo longer taking part
- Hospital Universitario Virgen De ValmeSevilla, SpainNo longer taking part
- Consorcio Hospital General Universitario de ValenciaValencia, SpainNo longer taking part
- Hospital Alvaro CunqueiroVigo, SpainNo longer taking part
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.