NCT07370649 Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
| NCT ID | NCT07370649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pomeranian Medical University Szczecin |
| Condition | Human Immunodeficiency Virus (HIV)-1 Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2026-05-12 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: \- Lack of patient consent for use of clinical data for research purposes
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07370649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Human Immunodeficiency Virus (HIV)-1 Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07370649 currently recruiting?
Yes, NCT07370649 is actively recruiting participants. Contact the research team at klinzak@pum.edu.pl for enrollment information.
Where is the NCT07370649 trial being conducted?
This trial is being conducted at Prague, Czechia, Frankfurt, Germany, Szczecin, Poland, Bydgoszcz, Poland and 3 additional locations.
Who is sponsoring the NCT07370649 clinical trial?
NCT07370649 is sponsored by Pomeranian Medical University Szczecin. The trial plans to enroll 250 participants.
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