HIV Infections
Conditions
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.
Interventions
DRUGVOCABRIA 30Mg Tablet
CAB 30 mg Film-coated tablets
RPV 25 mg film-coated tablets
CAB LA 600 mg prolonged release suspension for injection (3 mL)
RPV LA 900 mg prolonged release suspension for injection (3 mL)
BIOLOGICALIntact proviral DNA assay
HIV-1 latent reservoir size
BIOLOGICALFull-length sequencing
Proviral DNA
Sponsors
Swiss HIV Cohort Study
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants by treatment adherence category | Month 24 | \- Proportion of participants by treatment adherence categories (e.g., optimal, sub-optimal, and poor adherence) |
| 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 |
| 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 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) |
| 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 |
| 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-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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Switzerland
Contacts
Primary ContactDominique L Braun, MD
Backup ContactJessy J Duran Ramirez, MSc
Outcome results
None listed