Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03988725
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2019-06-12
Brief Title:
Nonalcoholic Steatohepatitis in HIV Mono-infection Exploring Non-invasive Methods for Diagnosis and the Therapeutic Role of Vitamin E
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Nonalcoholic Steatohepatitis in HIV Mono-infection Exploring Non-invasive Methods for Diagnosis and the Therapeutic Role of Vitamin E
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
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:
Effective combination antiretroviral therapy cART has resulted in a dramatic reduction in AIDS mortality Over the last decade the proportion of deaths caused by liver-related etiologies including co-infection with hepatitis C HCV and hepatitis B HBV viruses alcohol abuse and fatty liver has increased between 8 to 10 fold in the post-cART era while AIDS-related mortality has fallen more than 90-fold HIV infection without viral hepatitis is also at risk for liver disease Indeed HIV mono-infected persons experience common conditions such as obesity diabetes and dyslipidemia which are risk factors for non-alcoholic fatty liver disease NAFLD NAFLD is the most common liver disease in Canada It is a fatty infiltration of the liver that is not evolutive per se but it is the first histopathological step for non-alcoholic steatohepatitis NASH a progressive disease characterized by much inflammation leading to liver fibrosis and cirrhosis NASH may be frequent in the setting of HIV mono-infection due to excess of metabolic risk factors long-term cART HIV itself and lipodystrophy An early diagnosis of NASH is essential to establish a prognosis and initiate interventions to reduce progression of liver disease towards cirrhosis Early diagnosis of NASH is critical for targeting metabolic and hepatologic interventions which can impact on progression to cirrhosis and end-stage complications Non-invasive tools for liver fibrosis and NASH including FibroscanCAP and CK-18 are accurate and ideal for screening and serial monitoring No study has specifically targeted the non-invasive diagnosis of NASH in HIV mono-infected patients There has been no study about the use of CK-18 as a biomarker for NASH in the setting of HIV mono-infection Furthermore CAP has never been applied to this specific population Finally there is no data about the potential beneficial therapeutic effect of vitamin E on NASH associated to HIV infection The investigators hypothesize that CK-18 and FibroscanCAP can be used as non-invasive tests to diagnose NASH in HIV mono-infected persons Likewise the investigators hypothesize that there will be a significant prevalence of NASH diagnosed by non-invasive tools among patients with HIV mono-infection The investigators further hypothesize that a 6 months treatment trial with vitamin E supplementation will improve non-invasive diagnostic tests andor the metabolic and hepatic profile in HIV mono-infected patients with a non-invasive diagnosis of NASH
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