Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
HIV Infections, Fatty Liver
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, non-alcoholic fatty liver disease
Eligibility Criteria
Inclusion Criteria: Baseline liver biopsy with macrovesicular fatty degeneration with inflammation (lobular or portal), with or without Mallory bodies, hepatocyte damage, and/or fibrosis diagnostic of NAFLD Convincing evidence of negligible alcohol consumption (< 20 grams of ethanol per day) obtained from a detailed history, confirmed by at least one close relative If hyperlipidemia or diabetes, stable drug regimen required for the 6 months prior to and during the study Willingness to maintain stable weight and normal exercise program for the duration of the study, if randomized to vitamin E or betaine Exclusion Criteria: Liver disease of other etiology diagnosed as per routine medical investigation (e.g., chronic viral hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis or genetic liver disease such as Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, or biliary obstruction) Complications of liver disease such as recurrent variceal bleeding, resistant ascites, spontaneous portosystemic encephalopathy, or bacterial peritonitis Concurrent medical illness contra-indicating a liver biopsy, history of unexplained bleeding, hemophilia or abnormal coagulation results as per routine laboratory work-up or other reason judged by the hepatologist to contra-indicate a percutaneous liver biopsy Medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen, oxacillin or ampinovire) in the 6 months prior to entry Antioxidant vitamin supplementation, ursodeoxycholic acid, or any other experimental drug 6 months prior to study entry Pregnant or lactating
Sites / Locations
- University Health Network, Toronto General Hospital
Arms of the Study
Arm 1
Experimental
Vitamin E
alpha-tocoperol, capsules, 2 per day