Group A for Non-Alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Alcoholic Fatty Liver Disease (NAFLD)+2 MoreVitamin E - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether Vitamin E can help people with HIV who also have a fatty liver by seeing if the underlying liver condition gets better, worse, or stays the same.

Eligible Conditions
  • Non-Alcoholic Fatty Liver Disease (NAFLD)
  • Non-Alcoholic Fatty Liver Disease
  • Human Immunodeficiency Virus (HIV) Infection

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: at randomization visit (study day 1) and end of study visit (week 24)

Week 24
Determine the impact of vitamin E treatment on noninvasive markers of hepatic fibrosis
Determine the impact of vitamin E treatment on noninvasive markers of hepatic inflammation
Determine the impact of vitamin E treatment on noninvasive markers of systemic inflammation
Measure % change in liver fat content by magnetic resonance proton-density fat fraction

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Group A
1 of 2
Group B
1 of 2

Active Control

Non-Treatment Group

56 Total Participants · 2 Treatment Groups

Primary Treatment: Group A · Has Placebo Group · Phase 2

Group B
Drug
PlaceboComparator Group · 1 Intervention: Placebos · Intervention Types: Drug
Group A
Drug
ActiveComparator Group · 1 Intervention: Vitamin E · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at randomization visit (study day 1) and end of study visit (week 24)

Who is running the clinical trial?

Indiana University School of MedicineLead Sponsor
181 Previous Clinical Trials
142,135 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histological diagnosis of NASH.
You are HIV-positive and have a 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.