NCT00876733已完成不适用
Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 605
- 试验地点
- 66
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
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 ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or 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 ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or 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
Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
时间窗: 36 months
Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
次要结局
- Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Viral Load After 36 Months From Baseline.(Baseline and 36 months)
- Changes in the Laboratory Data (AST) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Laboratory Data (LDL Cholesterol) 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 Viral Load After 12 Months From Baseline.(Baseline and 12 months)
- Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.(Baseline and 12 months)
- Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the CD4+ Cell Count After 36 Months From Baseline.(Baseline and 36 months)
- Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Laboratory Data (ALT) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline(Baseline and 12 months)
- Changes in the Laboratory Data (Triglycerides) 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)
- Changes in the Laboratory Data (HDL Cholesterol) 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 (ALT) After 36 Months From Baseline(Baseline and 36 months)
- Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline(Baseline and 36 months)
研究者
研究点 (66)
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