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: Not yet recruiting
• Conditions: Human Immunodeficiency Virus

• Study Type: Observational
• Enrollment (Estimated): 600

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: 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

How is the study designed?

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	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		Months 5 and 11
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	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		Months 5 and 11
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 are adherent to treatment at 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		Month 11
Incidence of discontinuation of treatment over the study period	This measure will be reported in person/years	Month 11
Reasons for discontinuation of treatment over the study period	This measure will report all the reasons for which participants discontinued their treatment	Month 11
Time to discontinuation of treatment over the study period	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		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		Months 5 and 11
Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11		Months 5 and 11

Collaborators and Investigators

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

Study record dates

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

• 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)?: 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