Vitamin E for NASH Treatment in HIV Infected Individuals

1807274844

The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition (fatty liver) gets better, worse, or stays the same from taking Vitamin E.

2019-10-01

2021-03-08

2021-03-08

Terminated

Early phase I

3

Inclusion Criteria: 1. males and females ≥18 years with biopsy-proven NASH within 6 months prior to enrollment 2. histological diagnosis of NASH will be confirmed by an experienced liver pathologist before study entry 3. HIV infection 4. stable dose of anti-diabetic agents and ART in the 3 months preceding enrollment and expected by the physician treating diabetes and HIV to remain on stable medications during the study 5. willingness to participate in the study 6. ability to understand and give informed consent for participation Exclusion Criteria: 1. Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilson disease, hemochromatosis, etc.) 2. average alcohol consumption \>3 drinks/day for men or \>2 drinks/day for women in the 6 months prior to enrollment. 3. Alcohol Use Disorder Identification Test (AUDIT) score of ≥8 4. evidence of cirrhosis on histology or imaging 5. ongoing use of medications known to cause hepatic steatosis (e.g., corticosteroids, amiodarone, methotrexate, tetracycline, tamoxifen, estrogens at doses greater than those used for birth control, anabolic steroids, or valproic acid) 6. prior bariatric surgery 7. severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness) 8. allergy to vitamin E 9. use of vitamin E or multivitamins containing vitamin E in the three months preceding enrollment 10. use of drugs with potential effect on NASH such as ursodeoxycholic acid, S-adenosylmethionine (SAM-e), betaine, pentoxifylline, or milk thistle in the three months prior to enrollment. 11. changing doses of statins (simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, fenofibrate) in the three months prior enrollment. 12. illicit substance abuse within the past twelve months 13. breast feeding, pregnancy, inability or unwillingness to practice contraception for the duration of the study 14. contraindications for the MRI procedure (e.g., prostheses, severe claustrophobia) 15. poorly controlled diabetes with A1C \>8.5 within in the last six months 16. use of total parenteral nutrition in the 6 months preceding liver biopsy or enrollment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A: Vitamin E 800 IU/daily for 24 weeks. (total of 28 subjects) Group B: Matching placebo for 24 weeks (total of 28 subjects)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Study biostatistician and Investigational Drug Services pharmacist will randomize subjects and will provide study drug', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 3, 'type': 'ACTUAL'}}

2023-07-25