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Liver Steatosis and Stiffness in HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599882
Recruitment Status : Unknown
Verified August 2018 by Yi-Cheng Chen, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : July 26, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Yi-Cheng Chen, Chang Gung Memorial Hospital

Study Description
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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

Condition or disease Intervention/treatment
HIV Infections Fatty Liver Liver Fibroses Device: Fibroscan

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Non-invasive Assessment of Liver Steatosis and Stiffness in HIV-infected Patients With Controlled Attenuation Parameter and Transient Elastography
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Intervention Details:
  • Device: Fibroscan
    Fibroscan with controlled attenuation parameter and transient elastography

Outcome Measures
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Primary Outcome Measures :
  1. The changes of liver steatosis in HIV-infected patients by FibroScan (CAP) [ Time Frame: 2 years ]
    The liver steatosis will be evaluated by controlled attenuation parameter at 6-month interval. The overtime changes will be explored.

  2. The changes of liver fibrosis in HIV-infected patients by Fibroscan (VCTE) [ Time Frame: 2 years ]
    The liver fibrosis will be assessed by transient elastography at 6-month interval. The overtime changes will be explored.


Secondary Outcome Measures :
  1. The association between FIB-4 and liver fibrosis [ Time Frame: 2 years ]
    FIB-4 will be calculated by a formula. FIB-4=[age(year)*AST(U/L)]/[platelet count*ALT(U/L)^0.5]

  2. The association between BMI and liver steatosis [ Time Frame: 2 years ]
    BMI is combination of BW and BH and presented as kg/m^2.

  3. The association between lipid profile and liver steatosis [ Time Frame: 2 years ]
    Lipid profile includes cholesterol, triglyceride, HDL cholesterol, LDL cholesterol.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with HIV infection
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599882


Contacts
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Contact: Yi-Cheng Chen, MD 886-3-3281200 ext 8107 yichengliver@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Yi-Cheng Chen, MD    886-3-3281200 ext 8107    yichengliver@gmail.com   
Sub-Investigator: Chun-Wen Cheng, MD         
Sub-Investigator: Fang-Hsueh Yuan         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Yi-Cheng Chen Chang Gung Memorial Hospital
More Information
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Additional Information:

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Responsible Party: Yi-Cheng Chen, Associate professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03599882    
Other Study ID Numbers: HIV-LSM-CAP
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yi-Cheng Chen, Chang Gung Memorial Hospital:
human immunodeficiency virus
liver steatosis
liver fibrosis
controlled attenuation parameter
transient elastography
Additional relevant MeSH terms:
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Fatty Liver
Liver Cirrhosis
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases