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NCT Number: NCT06424964

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

Recruiting

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint-Pierre University Hospital

Brussels, Belgium

Location status: Recruiting

Location contact

Stéphane De Wit

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV

    Time frame: Months 5 and 11

  2. Proportion of participants that experience loss of virologic suppression by month 11

    Time frame: Month 11

  3. 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.

  4. Proportion of participants with a viral blip at months 5 and 11

    Time frame: Months 5 and 11

  5. Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11

    Time frame: Months 5 and 11

  6. 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)

  7. Proportion of participants that discontinue their treatment over the study period

    Time frame: Month 11

  8. Incidence of discontinuation of treatment over the study period

    Time frame: Month 11

    This measure will be reported in person/years

  9. 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

  10. 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

  11. Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs

    Time frame: Within the first 12 weeks of the study

  12. Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11

    Time frame: Months 5 and 11

  13. Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11

    Time frame: Months 5 and 11

Study contacts

Contact information is provided by the study sponsor or research team.

Rakan Nasreddine, MD

CONTACT

[email protected]

+32 2 535 4130

Sponsors and collaborators

Lead sponsor

Belgian Research on AIDS and HIV Consortium

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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