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Non-invasive Assessment of Liver Steatosis and Stiffness in HIV-infected Patients With Controlled Attenuation Parameter and Transient Elastography
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
Age
20 - 65 years
Sex
ALL
Healthy Volunteers
No
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Start Date
August 1, 2018
Primary Completion Date
December 31, 2018
Completion Date
July 31, 2019
Last Updated
August 21, 2018
200
ESTIMATED participants
Fibroscan
DEVICE
Lead Sponsor
Chang Gung Memorial Hospital
NCT02815891
NCT07237750
Data Source & Attribution
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