Clinical trial

Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study: Uptake, Outcome, and Risk Factors for Treatment Failures in a Real-world Setting

Name

903_SHCS

Description

This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Moreover, the study aims to assess virological, immunological, demographic, clinical, and behavioural factors associated with viral failure under CAB+RPV LA regimen.

Trial arms

Trial start

2022-03-01

Estimated PCD

2025-12-31

Trial end

2026-06-30

Status

Recruiting

Treatment

VOCABRIA 30Mg Tablet

CAB 30 mg Film-coated tablets

Arms:

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

Other names:

Cabotegravir Tablets

EDURANT 25Mg Tablet

RPV 25 mg film-coated tablets

Arms:

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

Other names:

Rilpivirine Tablets

Cabotegravir Injectable Suspension

CAB LA 600 mg prolonged release suspension for injection (3 mL)

Arms:

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

Other names:

Vocabria

Rilpivirine Injectable Suspension

RPV LA 900 mg prolonged release suspension for injection (3 mL)

Arms:

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

Other names:

Rekambys

Intact proviral DNA assay

HIV-1 latent reservoir size

Arms:

Swiss HIV Cohort Study participants on CAB+RPV LA regimen, Swiss HIV Cohort Study participants on a standard of care oral regimen

Full-length sequencing

Proviral DNA

Arms:

Swiss HIV Cohort Study participants on CAB+RPV LA regimen, Swiss HIV Cohort Study participants on a standard of care oral regimen

Size

600

Primary endpoint

Proportion of individuals with viral blips

Month 24

Proportion of individuals with confirmed viral failures

Month 24

Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen

Month 24

Time to viral failure

Up to month 24

Proportion of participants who discontinue treatment due to drug-related reasons

Month 24

Proportion of participants who discontinue treatment due to drug-unrelated reasons

Month 24

Proportion of participants by characteristics

Month 24

Overall adherence to Swiss label indication in CAB+RPV LA prescriptions

Month 24

Overall adherence to the proposed injection schedules

Month 24

Proportion of participants by treatment adherence category

Month 24

Eligibility criteria

Inclusion Criteria: * Participant in the SHCS * All SHCS participants initiating the CAB+RPV LA regimen * All SHCS participants on SOC oral regimen Exclusion Criteria: * Not participating in the SHCS

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood (plasma and cell samples)'}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

Updated at

2024-05-08

1 organization

6 products

1 indication

Organization

University of Zurich

Product

VOCABRIA

Indication

HIV Infections

Product