Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin E for NASH Treatment in HIV Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669133
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Samer Gawrieh, Indiana University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
NAFLD NASH - Nonalcoholic Steatohepatitis HIV Infections Drug: Vitamin E Drug: Placebos Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
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
Primary Purpose: Treatment
Official Title: Vitamin E for NASH Treatment in HIV Infected Individuals
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Active Comparator: Group A
Vitamin E 800 IU/daily for 24 weeks
Drug: Vitamin E
Vitamin E 800 IU/daily

Placebo Comparator: Group B
Matching placebo for 24 weeks
Drug: Placebos
Matching placebo daily




Primary Outcome Measures :
  1. Measure % change in liver fat content by magnetic resonance proton-density fat fraction [ Time Frame: at randomization visit (study day 1) and end of study visit (week 24) ]
    MRI at randomization and completion visits to assess liver steatosis


Secondary Outcome Measures :
  1. Determine the impact of vitamin E treatment on noninvasive markers of hepatic inflammation [ Time Frame: at randomization visit (study day 1) and end of study visit (week 24) ]
    ALT(IU/L), AST (IU/L) , cytokeratin-18 (IU/L).

  2. Determine the impact of vitamin E treatment on noninvasive markers of systemic inflammation [ Time Frame: at randomization visit (study day 1) and end of study visit (week 24) ]
    TNF-alpha (pg/L), IL-10 (pg/L)

  3. Determine the impact of vitamin E treatment on noninvasive markers of hepatic fibrosis [ Time Frame: at randomization visit (study day 1) and end of study visit (week 24) ]
    liver stiffness by fibroscan (kPa)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669133


Contacts
Layout table for location contacts
Contact: Samer Gawrieh, MD 317-278-9326 sgawrieh@iu.edu
Contact: Regina Weber, BS, RRT 317-278-3584 reginaw@iu.edu

Locations
Layout table for location information
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Montreca Robison    317-278-0408    mgrobiso@iu.edu   
Contact: Regina Weber, BS, RRT    317-278-3584    reginaw@iu.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kathleen E Corey, MD       Kathleen.Corey@MGH.HARVARD.EDU   
Contact: Jenna L Gustafson    (617)724-3836    jlgustafson@partners.org   
Sponsors and Collaborators
Indiana University School of Medicine

Layout table for additonal information
Responsible Party: Samer Gawrieh, Associate Professor of Medicine, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT03669133     History of Changes
Other Study ID Numbers: 1807274844
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Samer Gawrieh, Indiana University School of Medicine:
Fatty liver
NAFLD
NASH
HIV
Vitamin E
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents