NCT01389310已完成不适用
Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe
Bristol-Myers Squibb9 个研究点 分布在 7 个国家目标入组 249 人开始时间: 2011年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 9
- 主要终点
- Number of Adverse events reported during Atazanavir drug exposure
研究概览
简要总结
The purpose of this study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected children participating in individual prospective paediatric HIV cohorts
- •Receive Atazanavir treatment during 01JAN2011 to 30DEC2013
- •Age <18 years old on the date starting an Atazanavir-containing regimen
- •Have a minimum of 3 months of follow-up
排除标准
- 未提供
结局指标
主要结局
Number of Adverse events reported during Atazanavir drug exposure
时间窗: 36 months
Timeframe of the study
次要结局
- Pattern of use of Atazanavir(36-months)
研究者
研究点 (9)
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