Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures
- Conditions
- HIV Infections
- Interventions
- Biological: Intact proviral DNA assayBiological: Full-length sequencing
- Registration Number
- NCT06405464
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Participant in the SHCS
- All SHCS participants initiating the CAB+RPV LA regimen
- All SHCS participants on SOC oral regimen
- Not participating in the SHCS
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Swiss HIV Cohort Study participants on CAB+RPV LA regimen Rilpivirine Injectable Suspension Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen Swiss HIV Cohort Study participants on CAB+RPV LA regimen Cabotegravir Injectable Suspension Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen Swiss HIV Cohort Study participants on CAB+RPV LA regimen EDURANT 25Mg Tablet Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen Swiss HIV Cohort Study participants on CAB+RPV LA regimen Full-length sequencing Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen Swiss HIV Cohort Study participants on a standard of care oral regimen Intact proviral DNA assay Matched control population on a standard of care oral regimen Swiss HIV Cohort Study participants on a standard of care oral regimen Full-length sequencing Matched control population on a standard of care oral regimen Swiss HIV Cohort Study participants on CAB+RPV LA regimen VOCABRIA 30Mg Tablet Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen Swiss HIV Cohort Study participants on CAB+RPV LA regimen Intact proviral DNA assay Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen
- Primary Outcome Measures
Name Time Method Proportion of participants by characteristics Month 24 - 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)
Overall adherence to Swiss label indication in CAB+RPV LA prescriptions Month 24 - 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
Proportion of individuals with viral blips Month 24 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)
Time to viral failure Up to month 24 Overall time to confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)
Proportion of participants who discontinue treatment due to drug-unrelated reasons Month 24 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.
Overall adherence to the proposed injection schedules Month 24 - 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)
Proportion of individuals with confirmed viral failures Month 24 Proportion of individuals with confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)
Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen Month 24 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
Proportion of participants who discontinue treatment due to drug-related reasons Month 24 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.
Proportion of participants by treatment adherence category Month 24 - Proportion of participants by treatment adherence categories (e.g., optimal, sub-optimal, and poor adherence)
- Secondary Outcome Measures
Name Time Method Measure intact proviral DNA as potential predictor for viral failure Month 24 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
Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure Month 24 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
Investigate in-depth factors associated with viral blips and viral failure Month 24 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)
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland