Vitamin E for NASH Treatment in HIV Infected Individuals
Condition: NAFLD; NASH - Nonalcoholic Steatohepatitis; HIV Infections
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Vitamin E; Placebo
Intervention description: Vitamin E 800 IU/daily; Matching placebo daily
Intervention MeSH terms: Vitamin E
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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)
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Study biostatistician and Investigational Drug Services pharmacist will randomize subjects and will provide study drug
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Fatty liver; NAFLD; NASH; HIV; Vitamin E

Summary:

      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.
    

Eligibility criteria:

        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