Liver Steatosis and Stiffness in HIV

• Conditions: HIV Infections; Fatty Liver; Liver Fibroses

• Registration Number: NCT03599882
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Status Verified: 2018-08
• Study Start: 2018-08-01
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21
• Primary Completion: 2018-12-31
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The changes of liver fibrosis in HIV-infected patients by Fibroscan (VCTE)	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)	2 years	The liver steatosis will be evaluated by controlled attenuation parameter at 6-month interval. The overtime changes will be explored.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan