- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06424964
Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
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
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rakan Nasreddine, MD
- Phone Number: +32 2 535 4130
- Email: rakan.nasreddine@stpierre-bru.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Participants will be asked to complete a 32-item paper questionnaire relating to their HIV treatment of LAI CAB/RPV.
Questions will focus on how their daily life and quality of life has been affected by switching to LAI CAB/RPV.
The questionnaire that will be used is not a standardized questionnaire but rather a questionnaire that was developped by the study team.
|
Within the first 12 weeks of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV
Time Frame: Months 5 and 11
|
Months 5 and 11
|
|
Proportion of participants that experience loss of virologic suppression by month 11
Time Frame: Month 11
|
Month 11
|
|
Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression
Time Frame: Month 11
|
If a participant experiences loss of virologic suppression, then if an HIV resistance test was performed at that time, the resistance-associated mutations observed will be reported.
|
Month 11
|
Proportion of participants with a viral blip at months 5 and 11
Time Frame: Months 5 and 11
|
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
|
Months 5 and 11
|
|
Proportion of participants that are adherent to treatment at months 5 and 11
Time Frame: Months 5 and 11
|
LAI CAB/RPV must be taken every two months, which therefore requires that a target date be specified in advance of when the next treatment injection should be.
This measure will evaluate the proportion of participants that presented to their clinic to receive their treatment either on the target date or within 7 days after (this will be considered adherent) and the proportion of participants that received their treatment more than 7 days after their target date (this will be considered non adherent)
|
Months 5 and 11
|
Proportion of participants that discontinue their treatment over the study period
Time Frame: Month 11
|
Month 11
|
|
Incidence of discontinuation of treatment over the study period
Time Frame: Month 11
|
This measure will be reported in person/years
|
Month 11
|
Reasons for discontinuation of treatment over the study period
Time Frame: Month 11
|
This measure will report all the reasons for which participants discontinued their treatment
|
Month 11
|
Time to discontinuation of treatment over the study period
Time Frame: Month 11
|
This measure will be reported by median time to discontinuation (months) and inter-quartile range
|
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
|
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
|
Months 5 and 11
|
|
Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11
Time Frame: Months 5 and 11
|
Months 5 and 11
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stéphane De Wit, MD/PhD, Belgian Research on AIDS & HIV Consortium
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 2024/1-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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