Evaluation en Vie réelle de la qualité de Vie de Personnes Vivant Avec le VIH traité Par cabotégravir et Rilpivirine Par Patient-Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 主要终点
- Treatment Impact - PROQOL-HIV
研究概览
简要总结
Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Its effects on the quality of life of PLHIV are explored in this research. In addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV, as well as compliance with the therapeutic window.
Main objective To evaluate the effect of switching HIV treatment to CAB+RPV LA on health-related quality of life on the "Treatment Impact" dimension of the PROQOL-HIV questionnaire, 15 months after switching treatment.
Population People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment
Study Design Observational study. Inclusion at HIV medical follow-up visit for change of ARV treatment to CAB/RPV.
Self-administered questionnaires at M3, M9 and M15 after change of treatment (first CAB/RPV injection).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 carriers
- •Patients who changed treatment (as part of routine care) to injectable CAB+RPV at the same visit as the inclusion visit
- •HIV-RNA less than or equal to 50 copies/mL for at least 6 months prior to inclusion visit
- •Patient 18 years of age or older
- •Patient able to read, understand and answer self-questionnaires in French
排除标准
- •Pregnant or breast-feeding women
- •Known hypersensitivity to cabotegravir or rilpivirine
- •Documented resistance to cabotegravir or rilpivirine
- •Chronically active hepatitis B (HBsAg+)
- •Any pathology or history of treatment which, in the investigator's judgment, would contraindicate the patient's inclusion in the study or prevent him/her from following the constraints of the protocol.
研究组 & 干预措施
PLWHIV
People living with HIV-1
干预措施: Cabotegravir, Rilpivirine Drug Combination (Drug)
结局指标
主要结局
Treatment Impact - PROQOL-HIV
时间窗: between D0 (baseline) and 15 months after the first injection of CAB+RPV LA
Evolution of the score of the "Treatment impact (TI)" dimension of the PROQOL-HIV questionnaire (10 items)
次要结局
未报告次要终点
研究者
Dr Martin Duracinsky
PhD, MD
Assistance Publique - Hôpitaux de Paris