Liver Steatosis and Stiffness in HIV

Study Overview
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Brief Summary
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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

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

Conditions
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Fatty Liver, HIV Infections, Liver Fibroses

Intervention / Treatment
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* Device: Fibroscan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fibroscan|Fibroscan with controlled attenuation parameter and transient elastography|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of liver steatosis in HIV-infected patients by FibroScan (CAP) | The liver steatosis will be evaluated by controlled attenuation parameter at 6-month interval. The overtime changes will be explored. | 2 years | 
| The changes of liver fibrosis in HIV-infected patients by Fibroscan (VCTE) | The liver fibrosis will be assessed by transient elastography at 6-month interval. The overtime changes will be explored. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between FIB-4 and liver fibrosis | FIB-4 will be calculated by a formula. FIB-4=[age(year)*AST(U/L)]/[platelet count*ALT(U/L)^0.5] | 2 years | 
| The association between BMI and liver steatosis | BMI is combination of BW and BH and presented as kg/m^2. | 2 years | 
| The association between lipid profile and liver steatosis | Lipid profile includes cholesterol, triglyceride, HDL cholesterol, LDL cholesterol. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human immunodeficiency virus, liver steatosis, liver fibrosis, controlled attenuation parameter, transient elastography