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Recruiting NCT06424964

Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium

— Observational Human Immunodeficiency Virus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Human Immunodeficiency Virus. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes. Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of HIV Secondary outcomes • Description of the demographic, HIV-, and non-HIV-related characteristics of participants included in this analysis

Primary outcome measures

  • Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV [Time frame: Within the first 12 weeks of the study]
Secondary outcome measures (12)
  • Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV [Time frame: Months 5 and 11]
  • Proportion of participants that experience loss of virologic suppression by month 11 [Time frame: Month 11]
  • Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression [Time frame: Month 11]
  • Proportion of participants with a viral blip at months 5 and 11 [Time frame: Months 5 and 11]
  • Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11 [Time frame: Months 5 and 11]
  • Proportion of participants that are adherent to treatment at months 5 and 11 [Time frame: Months 5 and 11]
  • Proportion of participants that discontinue their treatment over the study period [Time frame: Month 11]
  • Incidence of discontinuation of treatment over the study period [Time frame: Month 11]
  • Reasons for discontinuation of treatment over the study period [Time frame: Month 11]
  • Time to discontinuation of treatment over the study period [Time frame: Month 11]
  • Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs [Time frame: Within the first 12 weeks of the study]
  • Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11 [Time frame: Months 5 and 11]

Eligibility criteria

Inclusion criteria

  • HIV-1 patients, aged 18 years and above, having received at least 1 dose of LAI CAB/RPV between September 1, 2021, and March 31, 2024.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Saint-Pierre University Hospital — Brussels

Identifiers

NCT: NCT06424964 · 2024/1-12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗