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

May 17, 2024 updated by: Rakan Nasreddine, Belgian Research on AIDS and HIV Consortium

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

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited at one of the participating HIV reference centers (HRCs). These centers are part of the 12 official HIV treatment centers in Belgium and work in concert as members of the Belgian Research on AIDS & HIV Consortium (BREACH).

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

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

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

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

Investigators

  • Principal Investigator: Stéphane De Wit, MD/PhD, Belgian Research on AIDS & HIV Consortium

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Human Immunodeficiency Virus

3
Subscribe