Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
研究概览
简要总结
The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients infected by HIV-1 and HBV or HCV
- •Age ≥18 years
- •Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen
排除标准
- •Contraindications as described in SmPC (summary of product characteristics) at the time of prescription
研究组 & 干预措施
HIV-infected patients with hepatitis co-infection
HIV-infected patients with co-infections of Hepatitis B or Hepatitis C
干预措施: Lopinavir/Ritonavir (Kaletra) (Drug)
结局指标
主要结局
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
时间窗: Week 144
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
Viral Load
时间窗: Week 144
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
CD4 Cell Count
时间窗: Week 144
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.
次要结局
未报告次要终点