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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 60
- 主要终点
- Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
研究概览
简要总结
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.
详细描述
Study Design:
observational
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
时间窗: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in log10 Viral Load From Baseline to Last Visit
时间窗: 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.
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit
时间窗: 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.
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit
时间窗: 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.
次要结局
- Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade(Up to 185 months)
- Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade(Up to 185 months)
- Duration of Intake of Viramune(End of treatment, up to 185 months)
- Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade(Up to 185 months)
- Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade(Up to 185 months)
- Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade(Up to 185 months)
- Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade(Up to 185 months)
- Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade(Up to 185 months)
- History of Therapy With Antiretroviral Medication(Baseline)
- Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade(Up to 185 months)
- Number of Participants With Drug Related Adverse Events(Up to 185 months)
- Course of Absolute CD4+ Cell Count(Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months)