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

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Yonsei University

Status

Unknown

Conditions

HIV Infection

Treatments

Device: Acoustic radiation force impulse imaging

Study type

Observational

Funder types

Other

Identifiers

NCT01283243
1-2010-0027

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

HIV patients with normal liver status
Description:
HIV patients without abnormal liver function and chronic liver disease
Treatment:
Device: Acoustic radiation force impulse imaging

Trial contacts and locations

1

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Central trial contact

Kwang-Hyub Han, MD; Seung Up Kim, MD

Data sourced from clinicaltrials.gov

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