NCT03580668已完成不适用
Multi-center, Canadian, 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
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 6
- 主要终点
- Proportion 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 in accordance with the product monograph
排除标准
- •Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor
研究组 & 干预措施
B/F/TAF
Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy
干预措施: B/F/TAF (Drug)
结局指标
主要结局
Proportion 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
- Change in CD4 Cell Count at 3 Months(3 months)
- Change in CD4 Cell Count at 48 Months(48 months)
- CD4/CD8 Ratio at 3 Months(3 months)
- Proportion 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)
- Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF(36 months)
- Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF(60 months)
- Change in CD4 Cell Count at 12 Months(12 months)
- Change in CD4 Cell Count at 60 Months(60 months)
- CD4/CD8 Ratio at 6 Months(6 months)
- 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)
- Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF(48 months)
- CD4/CD8 Ratio at 24 Months(24 months)
- CD4/CD8 Ratio at 36 Months(36 months)
- Change in CD4 Cell Count at 6 Months(6 months)
- Proportion 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(12 months)
- CD4/CD8 Ratio at 48 Months(48 months)
- Proportion of Participants Experiencing Adverse Events (AEs)(60 months)
- Proportion of Participants Experiencing and Serious Adverse Events (SAEs)(60 months)
- Change in CD4 Cell Count at 24 Months(24 months)
- Change in CD4 Cell Count at 36 Months(36 months)
- CD4/CD8 Ratio at 60 Months(60 months)
研究者
研究点 (6)
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