NCT03599882

Liver Steatosis and Stiffness in HIV

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• HIV Infections
• Fatty Liver
• Liver Fibroses

Interventions

Type	Name	Description
DEVICE	Fibroscan	Fibroscan with controlled attenuation parameter and transient elastography

Timeline

• Start date: 2018-08-01
• Primary completion: 2018-12-31
• Completion: 2019-07-31
• First posted: 2018-07-26
• Last updated: 2018-08-21

Locations

1 site across 1 country: Taiwan