Antiretroviral Therapy and Extreme Weight
关键词
抽象
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.
Sample size:
It will be a descriptive experimental study involving 120 overweight subjects, 120 normal weight subjects
Inclusion criteria :
- Patients with HIV+
- Patients aged more than 18 years old.
- Patient giving its well-informed and free consent.
Study design :
Plasma concentration was performed during the usual clinical follow-up. Study duration: 12 months Duration for a patient: 1 day Investigating center and participating units: one center enrolling the patients and the lab performing drug dosages.
日期
| 最后验证: | 11/30/2013 |
| 首次提交: | 02/27/2013 |
| 提交的预估入学人数: | 03/04/2013 |
| 首次发布: | 03/05/2013 |
| 上次提交的更新: | 12/04/2013 |
| 最近更新发布: | 12/05/2013 |
| 实际学习开始日期: | 08/31/2012 |
| 预计主要完成日期: | 10/31/2013 |
| 预计完成日期: | 10/31/2013 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| patients treated with efavirenz HIV-infected on stable HAART regimen with efavirenz | |
| patients treated with atazanavir HIV-infected patients on stable HAART regimen with atazanavir | |
| patients treated with darunavir HIV-infected patients on stable HAART regimen with darunavir |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: Treatment with rifampin/rifabutin |
结果
主要结果指标
1. comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2 [the day of enrollment]
次要成果指标
1. comparison of the occurrence of virologic failure within each patient group [the day of enrollment]
其他成果措施
1. occurrence of adverse events in each patient group [the day of enrollment]
