Extreme Weights and Antiretroviral Therapy Individual Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2
研究概览
简要总结
The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according to the body weight or body composition and therapeutic monitoring may be necessary in overweight HIV patients.
The investigators aim at measuring the individual trough concentrations of interest [at steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.
详细描述
Our primary endpoint is the individual trough concentrations of interest at steady state for NNRTI or boosted PI; Principal outcome measure: comparison of the concentrations between patients <25kg/m2 and patients<25kg/m2
Secondary endpoints:
- Occurrence of virologic failure
- Occurrence of clinical/biological adverse events
- Percentage of patients with concentration within the therapeutic range
- Body composition Secondary outcome measures: comparison of the occurrence of virologic failure, occurrence or adverse event, patients with concentration within the therapeutic range between groups. Correlation between body composition and concentration.
Methodology, study design:
open-labelled monocentric study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HIV+ receiving one of the following third agent their HAART: efavirenz, atazanavir , or darunavir
- •Patients aged > 18 years old.
- •Patient giving its well-informed and free consent. Patient giving its well-informed and free consent.
- •Patients living in France during the study.
排除标准
- •Treatment with rifampin/rifabutin
结局指标
主要结局
comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2
时间窗: the day of enrollment
次要结局
- comparison of the occurrence of virologic failure within each patient group(the day of enrollment)
研究者
Stephane Mouly, MD PhD
MD PhD
Hopital Lariboisière