Clinical trial NCT06424964: Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
Official title: Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Immunodeficiency Virus
Lead sponsor: Belgian Research on AIDS and HIV Consortium
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV
timeFrame: Within the first 12 weeks of the study
Secondary outcomes:
measure: Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV
timeFrame: Months 5 and 11
measure: Proportion of participants that experience loss of virologic suppression by month 11
timeFrame: Month 11
measure: Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression
timeFrame: Month 11
measure: Proportion of participants with a viral blip at months 5 and 11
timeFrame: Months 5 and 11
measure: Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11
timeFrame: Months 5 and 11
measure: Proportion of participants that are adherent to treatment at months 5 and 11
timeFrame: Months 5 and 11
measure: Proportion of participants that discontinue their treatment over the study period
timeFrame: Month 11
measure: Incidence of discontinuation of treatment over the study period
timeFrame: Month 11
measure: Reasons for discontinuation of treatment over the study period
timeFrame: Month 11
measure: Time to discontinuation of treatment over the study period
timeFrame: Month 11
measure: Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs
timeFrame: Within the first 12 weeks of the study
measure: Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11
timeFrame: Months 5 and 11
measure: Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11
timeFrame: Months 5 and 11
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Saint-Pierre University Hospital
Study officials:
affiliation: Belgian Research on AIDS & HIV Consortium
name: Stéphane De Wit, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: