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.
The investigators will conduct a proof-of-concept clinical trial to evaluate the efficacy of vitamin E for treatment of non-alcoholic steatohepatitis (NASH) in persons living with HIV. Hypothesis: Vitamin E will improve radiographically measured hepatic fat content and circulating markers of liver inflammation and injury in persons living with HIV who have NASH. A. Perform a pilot randomized placebo controlled trial of vitamin E 800 IU/daily for 6 months in 56 persons living with HIV with biopsy-proven NASH B. Measure change in liver fat content by magnetic resonance proton-density fat fraction (Primary outcome) C. Determine the impact of vitamin E treatment on noninvasive markers of hepatic and systemic inflammation, hepatic fibrosis, and systemic oxidative stress (Secondary outcomes) D. Define baseline hepatic gene expression signatures predictive of response to therapy. Upon completion, the proposed clinical trial may establish vitamin E as an excellent and inexpensive candidate for further development as a treatment for NASH in persons living with HIV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3
Indiana University School of Medicine
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction
change in liver steatosis via MRI-PDFF at randomization (day 1) and study completion (week 24) to assess liver steatosis
Time frame: at randomization visit (study day 1) and end of study visit (week 24)
Impact of Vitamin E Treatment on Noninvasive Markers of Hepatic Fibrosis
This outcome measure reflects the change in liver stiffness in transient elastrography via FibroScan is measured in (kPa) for study participants at two study time points
Time frame: change from baseline (first screening visit) to the end of study visit (week 24)
Impact of Treatment on ALT as a Noninvasive Marker of Hepatic Inflammation
This measure reflects the change in ALT(IU/L) value for study participants at two study time points
Time frame: at randomization visit (study day 1) and end of study visit (week 24)
Impact of Treatment on AST as a Noninvasive Marker of Hepatic Inflammation
This measure reflects the change in AST(IU/L) value for study participants at two study time points
Time frame: Change in AST from study randomization (day 1) through the end of study visit (week 24)
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