Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study

Recruiting now

Conditions studied: Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection, HIV-1 Subtype B Infection, Virologically Suppressed HIV-1 Infection Receiving Long-Acting Antiretroviral Therapy

In brief

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.

Key facts

Study ID

NCT07370649

Run by

Pomeranian Medical University Szczecin

People needed

250

Starts

2026-05-12

Expected to finish

2027-03-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Lack of patient consent for use of clinical data for research purposes

Where it is running

• Wojewódzki Szpital Obserwacyjno-Zakaźny — Bydgoszcz, Poland (enrolling)
• MainFachArzt — Frankfurt, Germany (enrolling)
• Wrocławskie Centrum Zdrowia — Wroclaw, Poland (enrolling)
• Hospital Na Bulovce Praque HIV Centre, Department of Infectious Diseases — Prague, Czechia (enrolling)
• Szpitale Pomorskie — Gdansk, Poland (enrolling)
• Wojewódzki Szpital Zakaźny w Warszawie — Warsaw, Poland (enrolling)
• Katedra Chorób Zakaźnych i Niedoborów Immunologicznych — Szczecin, West Pomeranian Voivodeship, Poland

Full record on ClinicalTrials.gov

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