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Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

2014年6月27日 更新者：Boehringer Ingelheim
The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). An observation period of about 10 years extends far beyond the duration of clinical trials. First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.

研究概览

地位

完全的

条件

详细说明

Study Design:

observational

研究类型

观察性的

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
      • Aachen、德国
        • Boehringer Ingelheim Investigational Site 1
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 10
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 11
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 14
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 4
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 5
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 8
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 9
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 12
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 13
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 15
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 2
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 3
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 6
      • Berlin、德国
        • Boehringer Ingelheim Investigational Site 7
      • Bochum、德国
        • Boehringer Ingelheim Investigational Site 16
      • Bonn、德国
        • Boehringer Ingelheim Investigational Site 17
      • Bremen、德国
        • Boehringer Ingelheim Investigational Site 18
      • Dortmund、德国
        • Boehringer Ingelheim Investigational Site 19
      • Duisburg、德国
        • Boehringer Ingelheim Investigational Site 20
      • Düsseldorf、德国
        • Boehringer Ingelheim Investigational Site 21
      • Düsseldorf、德国
        • Boehringer Ingelheim Investigational Site 22
      • Düsseldorf、德国
        • Boehringer Ingelheim Investigational Site 23
      • Düsseldorf、德国
        • Boehringer Ingelheim Investigational Site 24
      • Frankfurt、德国
        • Boehringer Ingelheim Investigational Site 25
      • Frankfurt、德国
        • Boehringer Ingelheim Investigational Site 26
      • Frankfurt、德国
        • Boehringer Ingelheim Investigational Site 27
      • Freiburg、德国
        • Boehringer Ingelheim Investigational Site 28
      • Freiburg、德国
        • Boehringer Ingelheim Investigational Site 29
      • Freiburg、德国
        • Boehringer Ingelheim Investigational Site 30
      • Hamburg、德国
        • Boehringer Ingelheim Investigational Site 31
      • Hamburg、德国
        • Boehringer Ingelheim Investigational Site 32
      • Hamburg、德国
        • Boehringer Ingelheim Investigational Site 33
      • Hamburg、德国
        • Boehringer Ingelheim Investigational Site 34
      • Hamburg、德国
        • Boehringer Ingelheim Investigational Site 35
      • Hamburg、德国
        • Boehringer Ingelheim Investigational Site 36
      • Hannover、德国
        • Boehringer Ingelheim Investigational Site 37
      • Hannover、德国
        • Boehringer Ingelheim Investigational Site 38
      • Hannover、德国
        • Boehringer Ingelheim Investigational Site 39
      • Heidelberg、德国
        • Boehringer Ingelheim Investigational Site 40
      • Karlsruhe、德国
        • Boehringer Ingelheim Investigational Site 41
      • Koblenz、德国
        • Boehringer Ingelheim Investigational Site 42
      • Leipzig、德国
        • Boehringer Ingelheim Investigational Site 43
      • Mannheim、德国
        • Boehringer Ingelheim Investigational Site 44
      • Mannheim、德国
        • Boehringer Ingelheim Investigational Site 45
      • München、德国
        • Boehringer Ingelheim Investigational Site 46
      • München、德国
        • Boehringer Ingelheim Investigational Site 47
      • München、德国
        • Boehringer Ingelheim Investigational Site 48
      • München、德国
        • Boehringer Ingelheim Investigational Site 49
      • München、德国
        • Boehringer Ingelheim Investigational Site 50
      • Münster、德国
        • Boehringer Ingelheim Investigational Site 51
      • Münster、德国
        • Boehringer Ingelheim Investigational Site 52
      • Münster、德国
        • Boehringer Ingelheim Investigational Site 53
      • Oldenburg、德国
        • Boehringer Ingelheim Investigational Site 54
      • Osnabrück、德国
        • Boehringer Ingelheim Investigational Site 55
      • Saarbrücken、德国
        • Boehringer Ingelheim Investigational Site 56
      • Stuttgart、德国
        • Boehringer Ingelheim Investigational Site 57
      • Stuttgart、德国
        • Boehringer Ingelheim Investigational Site 58
      • Stuttgart、德国
        • Boehringer Ingelheim Investigational Site 59
      • Wuppertal、德国
        • Boehringer Ingelheim Investigational Site 60

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

patients

描述

Inclusion criteria The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843)

Exclusion criteria The exclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843).

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

  • 时间观点：追溯

队列和干预

团体/队列
艾滋病毒治疗

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
Change in log10 Viral Load From Baseline to Last Visit
大体时间：Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.
Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
大体时间：Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit
大体时间：Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit
大体时间：Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

次要结果测量

结果测量
措施说明
大体时间
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade
大体时间：Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade
大体时间：Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade
大体时间：Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade
大体时间：Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade
大体时间：Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade
大体时间：Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade
大体时间：Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade
大体时间：Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Duration of Intake of Viramune
大体时间：End of treatment, up to 185 months
Duration of intake of Viramune
End of treatment, up to 185 months
History of Therapy With Antiretroviral Medication
大体时间：Baseline
Participants with a history of therapy with antiretroviral medication.
Baseline
Course of Absolute CD4+ Cell Count
大体时间：Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months
The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.
Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months
Number of Participants With Drug Related Adverse Events
大体时间：Up to 185 months
Number of participants with drug related Adverse Events (AEs)
Up to 185 months

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

Boehringer Ingelheim

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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

2009年8月1日

初级完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2009年9月16日

首先提交符合 QC 标准的

2009年9月17日

首次发布 (估计)

2009年9月18日

研究记录更新

最后更新发布 (估计)

2014年6月30日

上次提交的符合 QC 标准的更新

2014年6月27日

最后验证

2014年6月1日

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

  • 1100.1535

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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