Ignite Creation Date:
2024-05-06 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03599882
Status:
UNKNOWN
Last Update Posted:
2018-08-21
First Post:
2018-07-04
Brief Title:
Liver Steatosis and Stiffness in HIV
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Non-invasive Assessment of Liver Steatosis and Stiffness in HIV-infected Patients With Controlled Attenuation Parameter and Transient Elastography
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None