Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 16
- 主要终点
- Summary of Change From Baseline in Creatinine to Last Value on Treatment
研究概览
简要总结
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Summary of Change From Baseline in Creatinine to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in Creatinine from baseline to the last value in treatment
Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in total cholesterol from baseline to the last value in treatment
Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in alanine aminotransferase (ALT) from baseline to the last value in treatment
Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in asparate aminotransferase (AST) from baseline to the last value in treatment
Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment
Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
Summary of Change From Baseline in Triglycerides to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in triglycerides from baseline to the last value in treatment
Summary of Change From Baseline in Glucose to Last Value on Treatment
时间窗: from baseline to last value on treatment in between 36 months
The change in Glucose from baseline to the last value in treatment
次要结局
- Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment(from baseline to last value on treatment in between 36 months)
- Summary of Change From Baseline in CD4+ Count to Last Value on Treatment(from baseline to last value on treatment in between 36 months)
- Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator(from baseline to last value on treatment in between 36 months)
- Investigator's Global Clinical Assessment of Patient General Health Status(from baseline to last value on treatment in between 36 months)