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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424964
• Other study ID #: 2024/1-12
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Belgian Research on AIDS and HIV Consortium
• Contact: Rakan Nasreddine, MD
• Phone: +32 2 535 4130
• Email: rakan.nasreddine[@]stpierre-bru.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: June 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Belgian Research on AIDS and HIV Consortium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV		Months 5 and 11
Secondary	Proportion of participants that experience loss of virologic suppression by month 11		Month 11
Secondary	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
Secondary	Proportion of participants with a viral blip at months 5 and 11		Months 5 and 11
Secondary	Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11		Months 5 and 11
Secondary	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
Secondary	Proportion of participants that discontinue their treatment over the study period		Month 11
Secondary	Incidence of discontinuation of treatment over the study period	This measure will be reported in person/years	Month 11
Secondary	Reasons for discontinuation of treatment over the study period	This measure will report all the reasons for which participants discontinued their treatment	Month 11
Secondary	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
Secondary	Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs		Within the first 12 weeks of the study
Secondary	Change in weight from baseline and a =10% weight gain from baseline at months 5 and 11		Months 5 and 11
Secondary	Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11		Months 5 and 11