Re-examination Study for General Drug Use to Assess the Safety and Efficacy of ISENTRESS in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 996
- 主要终点
- Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment
研究概览
简要总结
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Isentress through collecting the safety and efficacy information in usual practice according to the Re-examination Regulation for New Drugs.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 Infected Adults
- •Treated with Isentress 400 mg tablet within local label during the enrollment period
排除标准
- •Contraindication to Isentress according to the local label
结局指标
主要结局
Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment
时间窗: up to 14 days after last treatment
Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible)
时间窗: 6 months after treatment +/- 2 weeks
Proportions of patients with HIV-1 RNA levels of less than 50 milliliter
时间窗: 6 months after treatment +/- 2 weeks
Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter
时间窗: 6 months after treatment +/- 2 weeks
次要结局
未报告次要终点