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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03599882
Other study ID # HIV-LSM-CAP
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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