Liver Steatosis and Stiffness in HIV

NCT03599882 | Unknown

• 1 other identifier: HIV-LSM-CAP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.Age: 20-65 years
2. 2.Males and females with HIV infection diagnosed by infection doctors
3. 3.Willing and able to comply with the study requirements
4. 4.Willing and able to provide written informed consent to participate in the study
5. 5.Pregnancy
6. 6.Unable to complete the noninvasive procedure of VCTE and CAP
7. 7.Unwilling to provide written informed consent to participate in the study

Conditions

HIV Infections; Fatty Liver; Liver Fibroses

Keywords

human immunodeficiency virus; liver steatosis; liver fibrosis; controlled attenuation parameter; transient elastography

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• The association between FIB-4 and liver fibrosis

  2 years

• The association between BMI and liver steatosis

  2 years

• The association between lipid profile and liver steatosis

  2 years

Interventions

Fibroscan DEVICE

Fibroscan with controlled attenuation parameter and transient elastography

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with HIV infection

You may qualify if:

• Age: 20-65 years
• Males and females with HIV infection diagnosed by infection doctors
• Willing and able to comply with the study requirements
• Willing and able to provide written informed consent to participate in the study

You may not qualify if:

• Pregnancy
• Unable to complete the noninvasive procedure of VCTE and CAP
• Unwilling to provide written informed consent to participate in the study

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

HIV Infections; Fatty Liver; Liver Cirrhosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Slow Virus Diseases

Study Officials

• Yi-Cheng Chen

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Cheng Chen, MD

CONTACT

886-3-3281200; yichengliver@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: July 31, 2019
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)