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

Recruiting

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT06424964
• Lead Sponsor: Belgian Research on AIDS and HIV Consortium

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-22
• Study Start: 2025-01-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants that experience loss of virologic suppression by month 11	Month 11
Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression	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.
Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11	Months 5 and 11
Proportion of participants that discontinue their treatment over the study period	Month 11
Time to discontinuation of treatment over the study period	Month 11	This measure will be reported by median time to discontinuation (months) and inter-quartile range
Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs	Within the first 12 weeks of the study
Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV	Months 5 and 11
Proportion of participants with a viral blip at months 5 and 11	Months 5 and 11
Proportion of participants that are adherent to treatment at months 5 and 11	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)
Reasons for discontinuation of treatment over the study period	Month 11	This measure will report all the reasons for which participants discontinued their treatment
Incidence of discontinuation of treatment over the study period	Month 11	This measure will be reported in person/years
Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11	Months 5 and 11
Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11	Months 5 and 11

Trial Locations

Locations (1)

Saint-Pierre University Hospital; 🇧🇪 Brussels, Belgium