Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients Under the "New Drug Re-Examination"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 595
- 主要终点
- Percentage of Participants With Viral Load Below 400 Copies/mL
研究概览
简要总结
This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling in participants 2 years of age and older with human immunodeficiency virus type 1 (HIV-1) infection.
详细描述
Participants were observed for up to 48 weeks following the first dose of Kaletra. A follow-up visit took place 1-2 weeks after treatment initiation, and subsequent visits occurred at the discretion of the investigators, typically occurring every 3 months. Clinical/immunological/virological/laboratory status, Kaletra-containing regimen/concomitant medication information, and adverse event information were obtained at follow-up visits.
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
- 2 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 2 years of age and above with HIV-1 infection
- •Patients who were prescribed Kaletra treatment as per investigator's medical judgment
- •Patients who gave verbal or written authorization to use their personal and health data
- •Patients who started Kaletra treatment after study agreement was in place
排除标准
- •Patients with known hypersensitivity to lopinavir, ritonavir or any excipients of the Kaletra tablet
- •Patients who were being treated or will be treated with drugs that are contraindicated with Kaletra
- •Patients who have been treated with Kaletra
- •Patients participating in other clinical trials
结局指标
主要结局
Percentage of Participants With Viral Load Below 400 Copies/mL
时间窗: Week 24
Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
Number of Participants With Adverse Events
时间窗: From the start of treatment until 30 days after the last dose, up to 52 weeks
Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.
Number of Participants Who Interrupted or Discontinued Kaletra Treatment
时间窗: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment
At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).
Percentage of Participants With Viral Load Below 50 Copies/mL
时间窗: Week 48
Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
次要结局
- Change From Baseline in Viral Load(Week 24 & 48)
- Percentage of Participants With Confirmed Viral Resistance(From baseline through weeks 24 and 48)
- Mean Time to Treatment Failure(From baseline through weeks 24 and 48)
- Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts(From baseline to Weeks 24 and 48)