Clinical and Translational Science Institute Prospective Longitudinal Assessment of Coinfected Subjects With HIV/Hepatitis C for Endothelial Function Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)
研究概览
简要总结
The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).
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
Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)
时间窗: Baseline
Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
次要结局
- Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)(Week 52)
- Change in HOMA-IR(Baseline to Week 52)
- Reactive Hyperemia Index (RHI)(Week 52)
- Insulin Resistance by HOMA-IR(Week 52)
- Change in Framingham Risk Score (10-year Risk, %)(Baseline to Week 52)
- Framingham Risk Score (FRS), 10-year Risk (%)(Week 52)
- Change in RHI(Baseline to Week 52)
- Change in Level of Each Soluble Biomarker (Components of Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)(Baseline to Week 52)
研究者
Kara Chew
Assistant Clinical Professor
University of California, Los Angeles