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

May 6, 2024 updated by: University of Zurich

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jessy J Duran Ramirez, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
CAB 30 mg Film-coated tablets
Other Names:
  • Cabotegravir Tablets
Drug: EDURANT 25Mg Tablet
RPV 25 mg film-coated tablets
Other Names:
  • Rilpivirine Tablets
Drug: Cabotegravir Injectable Suspension
CAB LA 600 mg prolonged release suspension for injection (3 mL)
Other Names:
  • Vocabria
Drug: Rilpivirine Injectable Suspension
RPV LA 900 mg prolonged release suspension for injection (3 mL)
Other Names:
  • Rekambys
Biological: Intact proviral DNA assay
HIV-1 latent reservoir size
Biological: Full-length sequencing
Proviral DNA
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
HIV-1 latent reservoir size
Biological: Full-length sequencing
Proviral DNA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of individuals with viral blips
Time Frame: 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)
Month 24
Proportion of individuals with confirmed viral failures
Time Frame: Month 24
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
Time Frame: 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
Month 24
Time to viral failure
Time Frame: Up to month 24
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
Time Frame: 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.
Month 24
Proportion of participants who discontinue treatment due to drug-unrelated reasons
Time Frame: 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.
Month 24
Proportion of participants by characteristics
Time Frame: 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)
Month 24
Overall adherence to Swiss label indication in CAB+RPV LA prescriptions
Time Frame: 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
Month 24
Overall adherence to the proposed injection schedules
Time Frame: 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)
Month 24
Proportion of participants by treatment adherence category
Time Frame: Month 24
- Proportion of participants by treatment adherence categories (e.g., optimal, sub-optimal, and poor adherence)
Month 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigate in-depth factors associated with viral blips and viral failure
Time Frame: 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)
Month 24
Measure intact proviral DNA as potential predictor for viral failure
Time Frame: 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
Month 24
Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure
Time Frame: 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
Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss HIV Cohort Study

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessy J Duran Ramirez, MSc, Department of Infectious Diseases and Hospital epidemiology, University Hospital Zürich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 903_SHCS
  • 222485 (Other Grant/Funding Number: ViiV Healthcare)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings