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Long-acting cabotegravir and rilpivirine injections in people with HIV-1 subtype A6

Looks back at medical records of adults with HIV-1 subtype A6 on injections.

Key facts

Who runs it
Pomeranian Medical University Szczecin
Where
Prague, CzechiaSee the siteAlso in 2 other countries, 6 sites
Trial code
Registry title
Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
Status
Recruiting
People taking part
250 people, planned
Started
12 May 2026
Expected to end
Mar 2027
Type of study
Observational, 3 groups
Treatments tested
  • Cabotegravir Plus Rilpivirine Long-Acting Injectable
Record updated
11 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults living with HIV-1 who have had at least one injection of long-acting cabotegravir plus rilpivirine in routine care. Their medical records are looked at after the fact.

Age
18 years or older when the long-acting cabotegravir plus rilpivirine treatment began
Sex
All sexes can join
Disease stage
Confirmed HIV-1 infection. Cohorts are HIV-1 subtype A6, subtype B, or subtype unknown at the start of treatment.
Earlier treatment
Must have received at least one dose of long-acting cabotegravir plus rilpivirine (CAB/RPV LA) as part of routine care.
Biomarker or test result
HIV-1 subtype A6 or subtype B, or unknown subtype. If the subtype was unknown at the start, a blood sample for proviral DNA genotyping is needed.

Main reasons for not taking part

  • Did not agree to the use of clinical data for research

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in Czechia

Also in 2 other countries, 6 sites

  • Hospital Na Bulovce Praque HIV Centre, Department of Infectious DiseasesPrague, CzechiaContact: David JilichTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • HIV-1 subtype A6

    This cohort includes adults living with HIV-1 with a confirmed subtype A6 infection who received at least one dose of long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) as part of routine clinical care. Participants are treatment-experienced and include individuals with suppressed or unsuppressed viral load at treatment initiation. Clinical outcomes, including virologic effectiveness, treatment persistence, adherence, and discontinuation, are assessed retrospectively using existing medical records. This cohort is matched with the subtype B cohort using propensity score methods.

    Treatment: Cabotegravir Plus Rilpivirine Long-Acting Injectable

  • HIV-1 Subtype B Cohort

    This cohort consists of adults living with HIV-1 with a confirmed subtype B infection who received long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) in routine clinical practice. Participants are selected and matched to the subtype A6 cohort based on predefined confounding variables, including age, gender, body mass index category, and CD4 cell nadir. Outcomes are evaluated retrospectively to provide a comparative real-world context for the subtype A6 cohort.

    Treatment: Cabotegravir Plus Rilpivirine Long-Acting Injectable

  • HIV-1 Subtype Unknown Cohort

    This cohort includes adults living with HIV-1 who received long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) and had no documented HIV-1 subtype at the time of treatment initiation. Participants are analyzed as an unmatched descriptive group. Retrospective clinical outcome data are collected from medical records. For selected participants, proviral DNA genotyping from blood samples is performed after initial analyses to explore the clinical relevance of HIV-1 subtype knowledge prior to switching to long-acting injectable therapy.

    Treatment: Cabotegravir Plus Rilpivirine Long-Acting Injectable

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Long-Acting Cabotegravir And Rilipivirine In People Living With HIV-1 Subtype A6. A Multicentre Real-world, Retrospective Matched Case Study
Plain-language title
Long-acting cabotegravir and rilpivirine injections in people with HIV-1 subtype A6Generated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 June 2026