Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Vitamin E for the treatment of Fatty Liver in Adults with HIV

This research study is looking to determine the effects of taking vitamin E, as compared to placebo, fatty liver, condition that occurs when fat builds up in the liver and can lead to liver failure and liver cancer.

Massachusetts General Hospital Vitamin E Fatty Liver Disease Infectious Diseases
6 visits over 7 months
Estimated Time Commitment
Any Sex/Gender, 18-years or older
May Be Eligible
Payment up to $225
May Be Offered
Survey, Blood draw, Medication, MRI scan
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

We are studying to see if Vitamin E can help decrease the amount of liver fat in adults with both non-alcoholic steatohepatitis (NASH), a type of fatty liver, and HIV. There is evident that Vitamin E can improve NASH in patients without HIV, but it has not been studied in adults living with HIV. 


Why it is important

Currently, there are no safe and effective therapies for individuals diagnosed with both NASH and HIV, even though there have been many efforts to treat NASH in patients without HIV. Taking part of this study will be the first important step in finding a line of therapy for these patients. 


What we hope to accomplish

This research study is hoping to determine if treatment with vitamin E can help improve the health of the liver in patients diagnosed with both NASH and HIV. 

Principal Investigator

Kathleen Corey, MD/MPH

Massachusetts General Hospital

Public Profile

Who can participate

Adults 18 years of order are welcome to pariticipate in this study if they have been diagnosed with biopsy-proven alcoholic steatohepatitis (NASH) and HIV. If you are interested in pariticipating, we will ask additional questions to further determine if you wualify for this study. 

Who cannot participate

Patients with other chronic liver disease, such as viral hepatitis B or C, autoimmune hepatitis, hemochromatosis or have signs of decompensated cirrhosis of the liver, have had bariatric surgery or cannot have a MRI, may not qualify for this study. 

What you may be asked to do

Participants in this study will be asked questions about their medical history and lifestyle behaviors; will be asked for blood samples; will undergo a "Fibroscan", which is an ultrasound of your liver, and a MRI; and are expected to take the study medication as prescribed. 


Project activities may include:

  • Survey
  • Blood draw
  • Medication
  • MRI scan

Estimated Time Commitment

6 visits over 7 months

What You May Get

$225 for completion of the study and parking compensation. 

Location

Massachusetts General Hospital, GI Associates, Wang Building, 5th Floor
55 Fruit Street, Boston MA 02114

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Travel

  • Parking reimbursed
  • Parking available
  • Accessible by public transportation

Travel and Parking Details

Massachusetts General Hospital has a few parking garages available for patients, and parking validation will be provided. Additionally, MGH is a 7 minute walk from the Charles/MGH red line T stop; or a 12 minute walk from the North Station orange line T stop - with a shuttle that can bring you to/from the stop and MGH. 

Additional Information

ClinicalTrials.gov Identifier

NCT03669133


Study Phase

Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.


Participating Institutions


Funding Source

  • NIH or Other Federal
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