NCT00615290已完成不适用
Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3
研究概览
简要总结
To obtain information on clinical practices for patients treated by Aptivus in real life
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 positive patients for whom Aptivus treatment is initiated by their physician
- •Aptivus SCP respect
排除标准
- •None if the inclusion criteria are respected: observational study
结局指标
主要结局
Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3
时间窗: 6 months after inclusion
The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3
次要结局
- Evaluation of Early Virological Response(1 month after inclusion)
- Viral Load Response at 1 Month(1 month after inclusion)
- CD4 Count at 1 Month(1 month after inclusion)
- Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL(3 months after inclusion)
- Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL(3 months after inclusion)
- Viral Load Response at 3 Months(3 months after inclusion)
- CD4 Count at 3 Months(3 months after inclusion)
- Patient Self Perception of the New Treatment(Day 0, month 3 and month 6)
研究者
研究点 (2)
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