Assessment of Normal Value of Acoustic Radiation Force Impulse (ARFI) Elastography in HIV Patients

• Conditions: HIV Infection
• Interventions: Device: Acoustic radiation force impulse imaging

• Registration Number: NCT01283243
• Lead Sponsor: Yonsei University

Brief Summary

This is a prospective cohort single center study for assessment of normal value of acoustic radiation force impulse elastography and fibroscan in HIV patients without abnormal liver function and chronic liver disease.

Detailed Description

HIV positive patients who have liver dysfunction have shown to be correlated with high mortality and morbidity. To date, ARFI elastography has been known to correlate with the degree of liver fibrosis in chronic liver disease. However, ARFI velocity has not yet been reported in HIV patients. The aim of this study was to identify the normal range of ARFI velocity and liver stiffness value by recruiting HIV patients without abnormal liver function and chronic liver disease.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age > 20 years
• HIV positive patients
• The patients who is willing and able to provide written informed consent to participate in this study

Exclusion Criteria

• Co-infected with HIV and HBV or HCV
• History of any other forms of liver disease
• Any gross abnormality on the imaging finding including MRI and CT
• Any laboratory abnormalities regarding liver condition (Platelet count < 150 x 103/ul, Fasting glucose > 110 mg/dl, AST > 40 IU/L, ALT> 40 IU/L, Albumin < 3.3 g/dl, Total bilirubin > 1.2 mg/dl, GGT> 54 IU/L, ALP > 115 IU/L , Ferritin > 322 ng/ml)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV patients with normal liver status	Acoustic radiation force impulse imaging	HIV patients without abnormal liver function and chronic liver disease

Primary Outcome Measures

Name	Time	Method
Evaluation of ARFI velocity in HIV patients	2 years	Measurement of ARFI velocity is non-invsive ultrasonographic technique. It is performed with a abdominal convex probe which is same probe as conventional ultrasonography. Short-duration acoustic radiation forces result in shear-wave propagation away from the region of excitation and are tracked using ultrasonic correlation-based methods. This results are called ARFI velocity which is expressed as meters per second

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of