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

NCT06424964 | Recruiting

• 1 other identifier: 2024/1-12
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

  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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

Sponsors & Collaborators

• Belgian Research on AIDS and HIV Consortium: lead

Study Sites (1)

Saint-Pierre University Hospital

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Stéphane De Wit, MD/PhD

  Belgian Research on AIDS & HIV Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakan Nasreddine, MD

CONTACT

+32 2 535 4130; rakan.nasreddine@stpierre-bru.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 22, 2024
• Study Start: January 13, 2025
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)