Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 728
- 主要终点
- Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed)
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 STOCRIN through collecting the safety and efficacy information 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
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 Infected Patient
- •Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.)
排除标准
- •Patient Who Has A Contraindication To Stocrin According To The Local Label
结局指标
主要结局
Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed)
时间窗: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment
Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment
时间窗: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment
Percent of patients with any adverse experience
时间窗: Up to 14 days following cessation of treatment
次要结局
未报告次要终点