Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroscan | Device | Fibroscan with controlled attenuation parameter and transient elastography |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The association between FIB-4 and liver fibrosis | FIB-4 will be calculated by a formula. FIB-4=[age(year)*AST(U/L)]/[platelet count*ALT(U/L)^0.5] | 2 years |
| The association between BMI and liver steatosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with HIV infection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Cheng Chen, MD | Contact | 886-3-3281200 | 8107 | yichengliver@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi-Cheng Chen | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan | 333 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
BMI is combination of BW and BH and presented as kg/m^2.
| 2 years |
| The association between lipid profile and liver steatosis | Lipid profile includes cholesterol, triglyceride, HDL cholesterol, LDL cholesterol. | 2 years |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012897 | Slow Virus Diseases |