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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
MainFachArzt
RECRUITING
Frankfurt
Poland
Wojewódzki Szpital Obserwacyjno-Zakaźny
RECRUITING
Bydgoszcz
Szpitale Pomorskie
RECRUITING
Gdansk
Katedra Chorób Zakaźnych i Niedoborów Immunologicznych
NOT_YET_RECRUITING
Szczecin
Wojewódzki Szpital Zakaźny w Warszawie
RECRUITING
Warsaw
Wrocławskie Centrum Zdrowia
RECRUITING
Wroclaw
Contact Information
Primary
Miłosz Parczewski, prof. dr hab. n. med.
klinzak@pum.edu.pl
+48 91 813 94 41
Backup
Karolina Sorbian-Gajewska
Time Frame
Start Date: 2026-05-12
Estimated Completion Date: 2027-03
Participants
Target number of participants: 250
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Pomeranian Medical University Szczecin
Collaborators: ViiV Healthcare

This content was sourced from clinicaltrials.gov