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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405464
• Other study ID #: 903_SHCS
• Secondary ID: 222485
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: University of Zurich
• Contact: Dominique L Braun, MD
• Phone: 0041442559196
• Email: dominique.braun[@]usz.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• VOCABRIA 30Mg Tablet
CAB 30 mg Film-coated tablets
• EDURANT 25Mg Tablet
RPV 25 mg film-coated tablets
• Cabotegravir Injectable Suspension
CAB LA 600 mg prolonged release suspension for injection (3 mL)
• Rilpivirine Injectable Suspension
RPV LA 900 mg prolonged release suspension for injection (3 mL)

Biological:
• Intact proviral DNA assay
HIV-1 latent reservoir size
• Full-length sequencing
Proviral DNA

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss HIV Cohort Study

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Time to viral failure	Overall time to confirmed viral failures (defined as two consecutive HIV-1 RNA = 50 c/mL)	Up to month 24
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Investigate in-depth factors associated with viral blips and viral failure	Proportion of individuals by risk factor(s) (e.g., by body mass index, race, geographic origin, education, HIV-1 RNA levels, CD4 cell count, duration of HIV-1 infection, HIV-1 subtype, previous regimen, treatment adherence, CAB+RPV LA plasma concentrations measured at time of failure, genotypic resistance profile , lifestyle variables, and co-medications)	Month 24
Secondary	Measure intact proviral DNA as potential predictor for viral failure	Measure intact proviral DNA as potential predictor for viral failure among PWH initiating CAB+RPV LA regimen and compare with the matched control population on a SOC oral regimen	Month 24
Secondary	Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure	Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure among PWH initiating CAB+RPV LA regimen and compare with the matched control population on a SOC oral regimen	Month 24