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Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

2011年11月16日更新者：Abbott

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.

研究概览

地位

完全的

条件

Human Immunodeficiency Virus-Infection

干预/治疗

药品：Lopinavir/Ritonavir (Kaletra)

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

德国
- - Berlin、德国、10243
    - Site Reference ID/Investigator# 27575
  - Berlin、德国、10961
    - Site Reference ID/Investigator# 27592
  - Dortmund、德国、44137
    - Site Reference ID/Investigator# 27588
  - Frankfurt、德国、60311
    - Site Reference ID/Investigator# 27583
  - Frankfurt、德国、60596
    - Site Reference ID/Investigator# 27587
  - Hamburg、德国、20099
    - Site Reference ID/Investigator# 27607
  - Krefeld、德国、47800
    - Site Reference ID/Investigator# 5355
  - Muenster、德国、48149
    - Site Reference ID/Investigator# 27604

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections

描述

Inclusion Criteria:

Patients infected by HIV-1 and HBV or HCV
Age ≥18 years
Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen

Exclusion Criteria:

- Contraindications as described in SmPC (summary of product characteristics) at the time of prescription

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列	干预/治疗
HIV-infected patients with hepatitis co-infection HIV-infected patients with co-infections of Hepatitis B or Hepatitis C	药品：Lopinavir/Ritonavir (Kaletra) 3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Baseline	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 Baseline are presented.	Baseline
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 4	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 4 are presented.	Week 4
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 12	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 12 are presented.	Week 12
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 24	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 24 are presented.	Week 24
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 36	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 36 are presented.	Week 36
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 48	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 48 are presented.	Week 48
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 60	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 60 are presented.	Week 60
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 72	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 72 are presented.	Week 72
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 84	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 84 are presented.	Week 84
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 96	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 96 are presented.	Week 96
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 108	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 108 are presented.	Week 108
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 120	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 120 are presented.	Week 120
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：Week 132	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 132 are presented.	Week 132
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters 大体时间：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.	Week 144
Viral Load 大体时间：Baseline	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 Baseline are presented.	Baseline
Viral Load 大体时间：Week 4	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 4 are presented.	Week 4
Viral Load 大体时间：Week 12	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 12 are presented.	Week 12
Viral Load 大体时间：Week 24	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 24 are presented.	Week 24
Viral Load 大体时间：Week 36	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 36 are presented.	Week 36
Viral Load 大体时间：Week 48	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 48 are presented.	Week 48
Viral Load 大体时间：Week 60	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 60 are presented.	Week 60
Viral Load 大体时间：Week 72	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 72 are presented.	Week 72
Viral Load 大体时间：Week 84	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 84 are presented.	Week 84
Viral Load 大体时间：Week 96	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 96 are presented.	Week 96
Viral Load 大体时间：Week 108	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 108 are presented.	Week 108
Viral Load 大体时间：Week 120	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 120 are presented.	Week 120
Viral Load 大体时间：Week 132	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 132 are presented.	Week 132
Viral Load 大体时间：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.	Week 144
CD4 Cell Count 大体时间：Baseline	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 Baseline are presented.	Baseline
CD4 Cell Count 大体时间：Week 4	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 4 are presented.	Week 4
CD4 Cell Count 大体时间：Week 12	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 12 are presented.	Week 12
CD4 Cell Count 大体时间：Week 24	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 24 are presented.	Week 24
CD4 Cell Count 大体时间：Week 36	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 36 are presented.	Week 36
CD4 Cell Count 大体时间：Week 48	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 48 are presented.	Week 48
CD4 Cell Count 大体时间：Week 60	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 60 are presented.	Week 60
CD4 Cell Count 大体时间：Week 72	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 72 are presented.	Week 72
CD4 Cell Count 大体时间：Week 84	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 84 are presented.	Week 84
CD4 Cell Count 大体时间：Week 96	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 96 are presented.	Week 96
CD4 Cell Count 大体时间：Week 108	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 108 are presented.	Week 108
CD4 Cell Count 大体时间：Week 120	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 120 are presented.	Week 120
CD4 Cell Count 大体时间：Week 132	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 132 are presented.	Week 132
CD4 Cell Count 大体时间：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.	Week 144

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Abbott

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2001年5月1日

初级完成 (实际的)

2010年11月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2010年2月26日

首先提交符合 QC 标准的

2010年6月28日

首次发布 (估计)

2010年6月30日

研究记录更新

最后更新发布 (估计)

2011年12月19日

上次提交的符合 QC 标准的更新

2011年11月16日

最后验证

2011年11月1日

Lopinavir/Ritonavir (Kaletra)的临床试验

Fundacion SEIMC-GESIDA
Abbott

完全的

与 ZDV + 3TC + ABC 相比，洛匹那韦/利托那韦单药治疗患者的脂肪萎缩预防 (KALIPO)

艾滋病毒感染 | 爱滋病毒感染

西班牙
Germans Trias i Pujol Hospital
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud...

完全的

与包括 Kaletra + 类似物在内的三联疗法相比，Kaletra + Nevirapine 作为维持性双药治疗对 HIV 患者的影响研究

艾滋病毒感染

西班牙
Therapeutic Concepts
Abbott; Tibotec, Inc; BluKyne

完全的

Kaletra 和 Intelence 片剂在天真的受试者中的试点研究 (KALYINTE)

艾滋病毒感染

美国
Ain Shams University

未知

基于 Qurevo 加利巴韦林治疗血液透析患者伴或不伴肝硬化的丙型肝炎的疗效和安全性

慢性丙型肝炎

埃及
Assiut University

完全的

慢性肾病与终末期肾病患者中慢性 HCV 患者治疗的评估

丙型肝炎

埃及
The HIV Netherlands Australia Thailand Research...
Chulalongkorn University; Bamrasnaradura Infectious Diseases Institute

完全的

利福布汀 150 mg 每日一次与利福布汀 300 mg 每周三次的药代动力学和安全性

艾滋病病毒 | 结核

泰国
American Research Corporation
AbbVie

完全的

一项调查真实世界患者 HCV 反应率的研究：HEARTLAND 研究 (HEARTLAND)

慢性丙型肝炎
University of California, San Francisco

完全的

草药（非洲马铃薯）和抗逆转录病毒药物（洛匹那韦/利托那韦）之间的药代动力学相互作用 (AP6142)

人类免疫缺陷病毒 | 药物相互作用

美国
Assiut University
Sohag University; South Valley University

完全的

Ombitasvir/ Paritaprevir / Ritonavir 加利巴韦林治疗 HCV 和终末期肾病

晚期肾脏疾病 | HCV合并感染

埃及
AbbVie (prior sponsor, Abbott)

完全的

Kaletra 依从性支持援助 (KASA) 计划的真实有效性

人类免疫缺陷病毒感染

Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

取样方法

研究人群

描述

学习计划

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

合作者和调查者

赞助

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (估计)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

Lopinavir/Ritonavir (Kaletra)的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Jamaica

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点