Human Immunodeficiency Virus
Conditions
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
Interventions
None listed
Sponsors
Belgian Research on AIDS and HIV Consortium
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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) |
| Proportion of participants that discontinue their treatment over the study period | Month 11 | — |
| Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV | Months 5 and 11 | — |
| Reasons for discontinuation of treatment over the study period | Month 11 | This measure will report all the reasons for which participants discontinued their treatment |
| Time to discontinuation of treatment over the study period | Month 11 | This measure will be reported by median time to discontinuation (months) and inter-quartile range |
| 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 | — |
| Incidence of discontinuation of treatment over the study period | Month 11 | This measure will be reported in person/years |
Countries
Belgium
Contacts
Primary ContactRakan Nasreddine, MD
Outcome results
None listed