NCT07370649Recruiting
Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
Long-Acting Cabotegravir And Rilipivirine In People Living With HIV-1 Subtype A6. A Multicentre Real-world, Retrospective Matched Case Study
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
This study evaluates the real-world effectiveness and safety of a long-acting injectable HIV treatment consisting of cabotegravir and rilpivirine in people living with HIV-1. The focus is on individuals with HIV-1 subtype A6, which is common in Eastern Europe and among people who acquired HIV in that region, and on comparison with individuals with subtype B and those with an unknown subtype. Although long-acting cabotegravir and rilpivirine are widely used and effective, limited real-world data are available on how well this treatment works in people with HIV-1 subtype A6. This is important because subtype A6 has been suggested as a potential risk factor for treatment failure, but current evidence is inconclusive. The study uses existing medical records from treatment centers in Poland, Germany, and the Czech Republic. It includes adults with HIV who have received at least one injection of long-acting cabotegravir and rilpivirine and follows their clinical outcomes for up to 24 months. Researchers will assess viral suppression, treatment persistence, adherence to injection schedules, and reasons for treatment discontinuation. The results of this study will help clinicians better understand whether HIV-1 subtype A6 affects treatment outcomes and whether knowing a patient's HIV subtype is important when deciding to switch to long-acting injectable therapy. The findings may support safer and more effective use of this treatment in diverse patient populations.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 12 May 2026
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Pomeranian Medical University Szczecin
- Diseases
- HIV
- NCT number
- NCT07370649
What you commit to
- Study type: Observational
- Planned participants: 250
- From 12 May 2026 to the primary completion date, 1 Feb 2027
- 7 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Lack of patient consent for use of clinical data for research purposes
Who the study is looking for
- Confirmed diagnosis of HIV-1 infection
- Age ≥18 years at the time of initiation of long-acting cabotegravir plus rilpivirine (CAB/RPV LA)
- Received at least one dose of CAB/RPV LA as part of routine clinical care
- Availability of relevant clinical data in medical records for retrospective analysis
- Signed informed consent for use of clinical data
- Agreement to provide an additional blood sample for proviral DNA genotyping, if HIV-1 subtype was unknown at treatment initiation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Na Bulovce Praque HIV Centre, Department of Infectious Diseases Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| MainFachArzt Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| Wojewódzki Szpital Obserwacyjno-Zakaźny Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Szpitale Pomorskie Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Katedra Chorób Zakaźnych i Niedoborów Immunologicznych Coordinator of this site? Confirm its status | Szczecin | Poland | Not yet recruiting |
| Wojewódzki Szpital Zakaźny w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Wrocławskie Centrum Zdrowia Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.