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临床试验/NCT03599882
NCT03599882Unknown不适用

Non-invasive Assessment of Liver Steatosis and Stiffness in HIV-infected Patients With Controlled Attenuation Parameter and Transient Elastography

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年8月1日最近更新:
适应症

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:

  1. Age: 20-65 years
  2. Males and females with HIV infection diagnosed by infection doctors
  3. Willing and able to comply with the study requirements
  4. Willing and able to provide written informed consent to participate in the study

Exclusion criteria:

  1. Pregnancy
  2. Unable to complete the noninvasive procedure of VCTE and CAP
  3. 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

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

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Cheng Chen

Associate professor

Chang Gung Memorial Hospital

研究点 (1)

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