Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 34
- 主要终点
- Number of Patients With Virologic Response (VR) After 36 Months
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). 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 depending on gender 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
Time Perspective:
retro- and prospective
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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 Patients With Virologic Response (VR) After 36 Months
时间窗: 36 months
VR is defined as HIV viral load of \< 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml.
次要结局
- Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data ( ALT) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Viral Load After 36 Months From Baseline(Baseline and 36 months)
- Changes in the CD4+ Cell Count After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (AST) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline(Baseline and 36 months)