Korean Post-marketing Surveillance for Reyataz®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 601
- 试验地点
- 1
- 主要终点
- Adverse events occurrence
研究概览
简要总结
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA
排除标准
- •According to Warning/Caution in local label
研究组 & 干预措施
Patients ≥ 13 years of age with HIV-1
Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA
干预措施: No Intervention (Drug)
结局指标
主要结局
Adverse events occurrence
时间窗: 30 days after last dose of study drug
Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period
次要结局
- Overall efficacy evaluation by investigator's discretion(Baseline and 16 weeks after first treatment)
- Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration(Baseline and 16 weeks after first treatment)
- CD 4 T-cell count before and after drug administration(Baseline and 16 weeks after first treatment)