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

NCT06405464 | Recruiting

• 2 other identifiers: 903_SHCS222485
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (10)

• Proportion of individuals with viral blips

  Proportion of individuals with viral blips (defined as one HIV-1 RNA \>50 and \<400 c/mL with a next HIV-1 RNA \<50 copies/ml)

  Month 24

• Proportion of individuals with confirmed viral failures

  Proportion of individuals with confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)

  Month 24

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

  Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen after HIV-1 RNA levels of \>50 to \<400 copies/mL and \>400 copies/mL

  Month 24

• Time to viral failure

  Overall time to confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)

  Up to month 24

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

  Proportion of participants who discontinue treatment due drug-related reasons and re-suppression regimens (such as adverse events, confirmed viral failure, low level viremia or low blood concentration measurements) including the choice of re-suppression regimens.

  Month 24

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

  Proportion of participants who discontinue treatment due drug-unrelated reasons and re-suppression regimens (such as patient wish, death, migration, and loss to follow-up) including the choice of re-suppression regimens.

  Month 24

• Proportion of participants by characteristics

  \- Proportion of participants by socio-demographic and clinical characteristic(s) (e.g., by age, sex, body mass index, race, geographic origin, education, transmission mode, HIV-1 RNA levels, CD4 cell count, duration of HIV-1 infection, HIV-1 subtype, previous regimen, genotypic resistance profile, coinfections, lifestyle variables, and co-medications)

  Month 24

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

  \- Overall adherence to Swiss label indication in CAB+RPV LA prescriptions between care providers, such as university hospital versus private physicians, and among nationwide centres

  Month 24

• Overall adherence to the proposed injection schedules

  \- Overall adherence to the proposed injection schedules quantified by deriving an CAB+RPV LA adherence threshold (e.g., accounting for any missed injection, daily oral bridging ART, and delayed injection of +7 days according to the Swiss label indication)

  Month 24

• Proportion of participants by treatment adherence category

  \- Proportion of participants by treatment adherence categories (e.g., optimal, sub-optimal, and poor adherence)

  Month 24

Secondary Outcomes (3)

• Investigate in-depth factors associated with viral blips and viral failure

  Month 24

• Measure intact proviral DNA as potential predictor for viral failure

  Month 24

• Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure

  Month 24

Study Arms (2)

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

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

Drug: VOCABRIA 30Mg Tablet; Drug: EDURANT 25Mg Tablet; Drug: Cabotegravir Injectable Suspension; Drug: Rilpivirine Injectable Suspension; Biological: Intact proviral DNA assay; Biological: Full-length sequencing

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

Matched control population on a standard of care oral regimen

Biological: Intact proviral DNA assay; Biological: Full-length sequencing

Interventions

VOCABRIA 30Mg Tablet DRUG

CAB 30 mg Film-coated tablets

Also known as: Cabotegravir Tablets

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

EDURANT 25Mg Tablet DRUG

RPV 25 mg film-coated tablets

Also known as: Rilpivirine Tablets

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

Cabotegravir Injectable Suspension DRUG

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

Also known as: Vocabria

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

Rilpivirine Injectable Suspension DRUG

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

Also known as: Rekambys

Swiss HIV Cohort Study participants on CAB+RPV LA regimen

Intact proviral DNA assay BIOLOGICAL

HIV-1 latent reservoir size

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 BIOLOGICAL

Proviral DNA

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

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 SHCS participants initiating the CAB+RPV LA regimen and a matched control population on a SOC oral regimen (including dual drug regimens)

You may qualify if:

• Participant in the SHCS
• All SHCS participants initiating the CAB+RPV LA regimen
• All SHCS participants on SOC oral regimen

You may not qualify if:

• Not participating in the SHCS

Sponsors & Collaborators

• University of Zurich: lead
• Swiss HIV Cohort Study: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma and cell samples)

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir; Tablets; Rilpivirine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jessy J Duran Ramirez, MSc

  Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique L Braun, MD

CONTACT

0041442559196; dominique.braun@usz.ch

Jessy J Duran Ramirez, MSc

CONTACT

00410446341911; jessy.duranramirez@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 8, 2024
• Study Start: March 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-04

Locations

CH (1)