Non-invasive Assessment of Liver Steatosis and Stiffness in HIV-infected Patients With Controlled Attenuation Parameter and Transient Elastography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The changes of liver fibrosis in HIV-infected patients by Fibroscan (VCTE)
研究概览
简要总结
Background:
With the advances in treatment and clinical care, individuals with human immunodeficiency virus (HIV) infection have experienced an increase in life expectancy. Liver disease is common among HIV-infected patients due to the shared routes of transmission of HIV and viral hepatitis. Nonalcoholic fatty liver disease (NAFLD) is the most common cause of elevated aminotransferases in HIV-monoinfected adults without HBV or HCV.
Vibration-controlled transient elastography (VCTE) has been shown to have good sensitivity and specificity for assessment of liver fibrosis in HIV and viral hepatitis coinfected patients, as well as in HIV-negative NASH population. Controlled attenuation parameter (CAP), a novel physical parameter developed using the postulate that fat affects ultrasound propagation, measures the ultrasound attenuation at the center frequency of the FibroScan®.
Study design:
This is a prospective observational study.
Objective:
The aim of this study is to evaluate the liver steatosis and fibrosis in HIV-infected patients by noninvasive methods of VCTE and CAP.
Methods:
Patient number: 200
Inclusion criteria:
- Age: 20-65 years
- Males and females with HIV infection diagnosed by infection doctors
- Willing and able to comply with the study requirements
- Willing and able to provide written informed consent to participate in the study
Exclusion criteria:
- Pregnancy
- Unable to complete the noninvasive procedure of VCTE and CAP
- Unwilling to provide written informed consent to participate in the study
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
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-65 years
- •Males and females with HIV infection diagnosed by infection doctors
- •Willing and able to comply with the study requirements
- •Willing and able to provide written informed consent to participate in the study
排除标准
- •Unable to complete the noninvasive procedure of VCTE and CAP
- •Unwilling to provide written informed consent to participate in the study
结局指标
主要结局
The changes of liver fibrosis in HIV-infected patients by Fibroscan (VCTE)
时间窗: 2 years
The liver fibrosis will be assessed by transient elastography at 6-month interval. The overtime changes will be explored.
The changes of liver steatosis in HIV-infected patients by FibroScan (CAP)
时间窗: 2 years
The liver steatosis will be evaluated by controlled attenuation parameter at 6-month interval. The overtime changes will be explored.
次要结局
- The association between lipid profile and liver steatosis(2 years)
- The association between FIB-4 and liver fibrosis(2 years)
- The association between BMI and liver steatosis(2 years)
研究者
Yi-Cheng Chen
Associate professor
Chang Gung Memorial Hospital
