NCT04009057已完成不适用
Multi-center, Israeli, Non-interventional, Cohort Study of the Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adult Patients Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 5
- 主要终点
- Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after Initiating or Switching to B/F/TAF
研究概览
简要总结
The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA < 50 copies/mL, at 12 months after initiating or switching to bictegravir/ emtricitabine/tenofovir alafenamide (B/F/TAF).
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
- •HIV-1 infection
- •Signed informed consent
- •Initiating treatment with B/F/TAF
排除标准
- •Participation in any interventional clinical trial
结局指标
主要结局
Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after Initiating or Switching to B/F/TAF
时间窗: 12 Months
次要结局
- Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months After Initiating or Switching to B/F/TAF(6 Months)
- CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF(24 Months)
- Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF(3 Months)
- Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF(12 Months)
- Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF(6 Months)
- Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF(24 Months)
- Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months After Initiating or Switching to B/F/TAF(3 Months)
- CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF(3 Months)
- Percentage of Participants Experiencing Adverse Events and Serious Adverse Events(24 Months)
- Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months After Initiating or Switching to B/F/TAF(24 Months)
- CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF(12 Months)
- CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF(6 Months)
研究者
研究点 (5)
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