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

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

Study Overview

• Status: Unknown
• Conditions: HIV Infections; Fatty Liver; Liver Fibroses
• Intervention / Treatment: Device: Fibroscan

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Yi-Cheng Chen, MD; Phone Number: 8107 886-3-3281200; Email: yichengliver@gmail.com
    • Sub-Investigator: Chun-Wen Cheng, MD
    • Sub-Investigator: Fang-Hsueh Yuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with HIV infection

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yi-Cheng Chen, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: liver fibrosis; liver steatosis; transient elastography; human immunodeficiency virus; controlled attenuation parameter
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis
• Other Study ID Numbers: HIV-LSM-CAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No