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

NCT ID: NCT06405464

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Swiss HIV Cohort Study participants on CAB+RPV LA regimen

Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen

VOCABRIA 30Mg Tablet

Intervention Type DRUG

CAB 30 mg Film-coated tablets

EDURANT 25Mg Tablet

Intervention Type DRUG

RPV 25 mg film-coated tablets

Cabotegravir Injectable Suspension

Intervention Type DRUG

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

Rilpivirine Injectable Suspension

Intervention Type DRUG

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

Intact proviral DNA assay

Intervention Type BIOLOGICAL

HIV-1 latent reservoir size

Full-length sequencing

Intervention Type BIOLOGICAL

Proviral DNA

Swiss HIV Cohort Study participants on a standard of care oral regimen

Matched control population on a standard of care oral regimen

Intact proviral DNA assay

Intervention Type BIOLOGICAL

HIV-1 latent reservoir size

Full-length sequencing

Intervention Type BIOLOGICAL

Proviral DNA

Interventions

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VOCABRIA 30Mg Tablet

CAB 30 mg Film-coated tablets

Intervention Type DRUG

EDURANT 25Mg Tablet

RPV 25 mg film-coated tablets

Intervention Type DRUG

Cabotegravir Injectable Suspension

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

Intervention Type DRUG

Rilpivirine Injectable Suspension

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

Intervention Type DRUG

Intact proviral DNA assay

HIV-1 latent reservoir size

Intervention Type BIOLOGICAL

Full-length sequencing

Proviral DNA

Intervention Type BIOLOGICAL

Other Intervention Names

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Cabotegravir Tablets Rilpivirine Tablets Vocabria Rekambys

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss HIV Cohort Study

NETWORK

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessy J Duran Ramirez, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dominique L Braun, MD

Role: CONTACT

0041442559196

Jessy J Duran Ramirez, MSc

Role: CONTACT

00410446341911

Facility Contacts

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Dominique L Braun, MD

Role: primary

0041442559196

Jessy J Duran Ramirez, MSc

Role: backup

0041446341911

Other Identifiers

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222485

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

903_SHCS

Identifier Type: -

Identifier Source: org_study_id

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