Clinical trial Recruiting at 6 sites Observational Ages 18 and up

Long-Acting HIV Treatment in People with HIV-1 Subtype A6 and Others

Official title: Long-Acting Cabotegravir And Rilipivirine In People Living With HIV-1 Subtype A6. A Multicentre Real-world, Retrospective Matched Case Study

Run by Pomeranian Medical University Szczecin · NCT07370649 · Data updated 2026-11-12

This real-world study tests long-acting cabotegravir and rilpivirine in adults with HIV-1, including subtype A6, by looking at how well it works and how safe it is in routine care.

More HIV (Human Immunodeficiency Virus) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorPomeranian Medical University Szczecin
Academic / other
Locations7 sites (Prague and 6 other locations)
StatusRecruiting
StartedMay 12, 2026
Main results expectedFebruary 1, 2027
Study endsMarch 2027
Registry record updatedJune 11, 2026
Trial IDNCT07370649 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) living with HIV-1 who started CAB/RPV LA in routine clinical practice and have usable medical records for retrospective analysis.

Probably not a fit

Individuals with insufficient data or who do not meet subtype analysis criteria may not derive clear insights from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, retrospective observational study uses medical records from treatment centers in Poland, Germany, and the Czech Republic to evaluate the real-world effectiveness and safety of long-acting cabotegravir plus rilpivirine (CAB/RPV LA) in adults with HIV-1. Participants are grouped by HIV-1 subtype (A6, B, unknown) and analyzed for virologic outcomes, treatment persistence, and adherence over 24 months. Subtype A6 cases are matched to subtype B controls using propensity scores to reduce confounding, while unknown subtypes are analyzed separately. Data collection spans initiation and follow-up visits at roughly 6, 12, 18, and 24 months, with proviral DNA genotyping performed for unknown subtypes as an exploratory step. The study relies on routinely collected clinical data from electronic and paper records and aims to illuminate real-world performance of CAB/RPV LA across subtypes.

Why it matters

Potential benefit: If successful, the study could clarify how well CAB/RPV LA works in diverse HIV-1 subtypes in routine care and inform treatment decisions.

How similar studies have gone: Previous real-world experiences with CAB/RPV LA suggest good effectiveness, but data by subtype A6 are limited and this study addresses that gap.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Hospital Na Bulovce Praque HIV Centre, Department of Infectious Diseases
    Prague, Czechia
    Recruiting
  • MainFachArzt
    Frankfurt, Germany
    Recruiting
  • Wojewódzki Szpital Obserwacyjno-Zakaźny
    Bydgoszcz, Poland
    Recruiting
  • Szpitale Pomorskie
    Gdansk, Poland
    Recruiting
  • Wojewódzki Szpital Zakaźny w Warszawie
    Warsaw, Poland
    Recruiting
  • Wrocławskie Centrum Zdrowia
    Wroclaw, Poland
    Recruiting
Show 1 more location
  • Katedra Chorób Zakaźnych i Niedoborów Immunologicznych
    Szczecin, West Pomeranian Voivodeship, Poland
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.