NCT03669133

Vitamin E for NASH Treatment in HIV Infected Individuals

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• NAFLD
• NASH - Nonalcoholic Steatohepatitis
• HIV Infections

Interventions

Type	Name	Description
DRUG	Vitamin E	Vitamin E 800 IU/daily
DRUG	Placebo	Matching placebo daily

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-03-08
• Completion: 2021-03-08
• First posted: 2018-09-13
• Last updated: 2023-07-25
• Results posted: 2023-07-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study