Liver Steatosis and Stiffness in HIV

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03599882
• Other study ID #: HIV-LSM-CAP
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2018
• Source: Chang Gung Memorial Hospital
• Contact: Yi-Cheng Chen, MD
• Phone: 886-3-3281200
• Email: yichengliver[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• HIV Infections
• Liver Cirrhosis
• Liver Fibroses

Intervention

Device:
• Fibroscan
Fibroscan with controlled attenuation parameter and transient elastography

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	The association between BMI and liver steatosis	BMI is combination of BW and BH and presented as kg/m^2.	2 years
Secondary	The association between lipid profile and liver steatosis	Lipid profile includes cholesterol, triglyceride, HDL cholesterol, LDL cholesterol.	2 years