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| ID | Type | Description | Link |
|---|---|---|---|
| 222485 | Other Grant/Funding Number | ViiV Healthcare |
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| Name | Class |
|---|---|
| Swiss HIV Cohort Study | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Swiss HIV Cohort Study participants on CAB+RPV LA regimen | Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen |
| |
| Swiss HIV Cohort Study participants on a standard of care oral regimen | Matched control population on a standard of care oral regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOCABRIA 30Mg Tablet | Drug | CAB 30 mg Film-coated tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique L Braun, MD | Contact | 0041442559196 | dominique.braun@usz.ch | |
| Jessy J Duran Ramirez, MSc | Contact | 00410446341911 | jessy.duranramirez@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jessy J Duran Ramirez, MSc | Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Recruiting | Zurich | 8091 | Switzerland |
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Blood (plasma and cell samples)
| EDURANT 25Mg Tablet | Drug | RPV 25 mg film-coated tablets |
|
|
| Cabotegravir Injectable Suspension | Drug | CAB LA 600 mg prolonged release suspension for injection (3 mL) |
|
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| Rilpivirine Injectable Suspension | Drug | RPV LA 900 mg prolonged release suspension for injection (3 mL) |
|
|
| Intact proviral DNA assay | Biological | HIV-1 latent reservoir size |
|
| Full-length sequencing | Biological | Proviral DNA |
|
| 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 |
| Month 24 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C584914 | cabotegravir |
| D013607 | Tablets |
| D000068696 | Rilpivirine |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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