Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- number of patients with neurologic and/or psychiatric adverse events
研究概览
简要总结
The frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. The inclusion and exclusion criteria for enrolling people living with HIV are at times so selective and the subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. These adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments.
This study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 infection
- •age > 18
- •treatment with rilpivirine, elvitegravir, or dolutegravir (for exposed patients)
- •treatment with none of these drugs (for non exposed patients)
- •capacity of reading French language
排除标准
- •drugs addiction (except for amyl nitriles ("poppers") and cannabis)
- •alcoholism
- •co-infection with hepatitis C virus
- •pregnant or breast feeding patient
结局指标
主要结局
number of patients with neurologic and/or psychiatric adverse events
时间窗: 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine
次要结局
未报告次要终点