Clinical trial NCT03599882: Liver Steatosis and Stiffness in HIV
Official title: Non-invasive Assessment of Liver Steatosis and Stiffness in HIV-infected Patients With Controlled Attenuation Parameter and Transient Elastography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Fatty Liver
Liver Fibroses
Keywords: human immunodeficiency virus
liver steatosis
liver fibrosis
controlled attenuation parameter
transient elastography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HIV infection

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


Eligibility criteria: 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

Primary outcomes:
measure: The changes of liver steatosis in HIV-infected patients by FibroScan (CAP)
timeFrame: 2 years
measure: The changes of liver fibrosis in HIV-infected patients by Fibroscan (VCTE)
timeFrame: 2 years
Secondary outcomes:
measure: The association between FIB-4 and liver fibrosis
timeFrame: 2 years
measure: The association between BMI and liver steatosis
timeFrame: 2 years
measure: The association between lipid profile and liver steatosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yi-Cheng Chen
role: PRINCIPAL_INVESTIGATOR
References: