Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV
时间窗: 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.
次要结局
- 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)
- 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 discontinue their treatment over the study period(Month 11)
- Time to discontinuation of treatment over the study period(Month 11)
- Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs(Within the first 12 weeks of the study)
- Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV(Months 5 and 11)
- Proportion of participants with a viral blip 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)
- Reasons for discontinuation of treatment over the study period(Month 11)
- Incidence of discontinuation of treatment over the study period(Month 11)
- 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)
研究者
Rakan Nasreddine
Head of Research
Belgian Research on AIDS and HIV Consortium