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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

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Na Bulovce Praque HIV Centre, Department of Infectious Diseases
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PragueCzechiaRecruiting
MainFachArzt
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FrankfurtGermanyRecruiting
Wojewódzki Szpital Obserwacyjno-Zakaźny
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BydgoszczPolandRecruiting
Szpitale Pomorskie
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GdanskPolandRecruiting
Katedra Chorób Zakaźnych i Niedoborów Immunologicznych
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SzczecinPolandNot yet recruiting
Wojewódzki Szpital Zakaźny w Warszawie
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WarsawPolandRecruiting
Wrocławskie Centrum Zdrowia
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WroclawPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.