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

NCT07370649 | Not Yet Recruiting

• 1 other identifier: LACRIS
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Virologically Suppressed HIV-1 Infection Receiving Long-Acting Antiretroviral Therapy; HIV-1 Subtype A6 Infection; HIV-1 Subtype B Infection; Human Immunodeficiency Virus (HIV)-1 Infection

Keywords

HIV-1; Long-Acting Antiretroviral Therapy; Cabotegravir; Rilpivirine; CAB/RPV LA; HIV-1 Subtype A6; HIV-1 Subtype B; Virologic Suppression; Real-World Study; Retrospective Study; Injectable HIV Therapy; Treatment Persistence; Virologic Failure

Outcome Measures

Primary Outcomes (1)

• Virologic Suppression at Follow-Up

  Proportion of participants with HIV-1 RNA viral load \<50 copies/mL at follow-up after initiation of long-acting cabotegravir plus rilpivirine (CAB/RPV LA), assessed using available clinical laboratory measurements. Virologic suppression will be evaluated at approximately 6, 12, 18, and 24 months after treatment initiation, with last observation carried forward where applicable.

  Up to 24 months after initiation of CAB/RPV LA

Secondary Outcomes (8)

• Treatment Persistence on CAB/RPV LA

  Up to 24 months after initiation of CAB/RPV LA

• Treatment Discontinuation Rate

  Up to 24 months after initiation of CAB/RPV LA

• Time to Treatment Discontinuation

  Up to 24 months after initiation of CAB/RPV LA

• Adherence to Injection Schedule

  Up to 24 months after initiation of CAB/RPV LA

• Delayed or Missed Injections

  Up to 24 months after initiation of CAB/RPV LA

Study Arms (3)

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.

Drug: 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.

Drug: 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.

Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable

Interventions

Cabotegravir Plus Rilpivirine Long-Acting Injectable DRUG

Cabotegravir plus rilpivirine long-acting (CAB/RPV LA) is a complete antiretroviral regimen administered as intramuscular injections and approved for the maintenance treatment of HIV-1 infection in adults. In this observational, retrospective study, CAB/RPV LA is used as part of routine clinical care and is not assigned by the study protocol. Participants received CAB/RPV LA according to local prescribing information, including dosing intervals and injection windows. The study evaluates real-world clinical outcomes of CAB/RPV LA across different HIV-1 subtype groups (subtype A6, subtype B, and unknown subtype). Outcomes of interest include virologic effectiveness, treatment persistence, adherence to injection schedules, and treatment discontinuation. No study-specific modifications to dosing, administration, or clinical management are performed.

Also known as: CAB/RPV LA, Long-Acting Cabotegravir and Rilpivirine, Cabotegravir + Rilpivirine

HIV-1 Subtype B Cohort; HIV-1 Subtype Unknown Cohort; HIV-1 subtype A6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults aged 18 years or older living with HIV-1 infection who have received 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 HIV-1 viral load at the time of treatment initiation. Patients are identified retrospectively from electronic medical records at participating HIV treatment centers in Poland, Germany, and the Czech Republic. Participants are grouped according to documented HIV-1 subtype (subtype A6, subtype B, or unknown subtype). Individuals with known subtype A6 are matched with individuals with subtype B based on selected clinical characteristics, while participants with unknown subtype are analyzed as an unmatched descriptive cohort. The study includes a broad, real-world patient population without upper age limits or sex-based restrictions, reflecting routine clinical practice in participating ce

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

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Katedra Chorób Zakaźnych i Niedoborów Immunologicznych

Szczecin, West Pomeranian Voivodeship, 71-455, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples collected for routine clinical care, with proviral DNA extracted from blood cells for HIV-1 genotyping in participants with unknown subtype.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

cabotegravir; Rilpivirine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Miłosz Parczewski, prof. dr hab. n. med.

CONTACT

+48 91 813 94 41; klinzak@pum.edu.pl

Karolina Sorbian-Gajewska

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)