Vitamin E for NASH Treatment in HIV Infected Individuals

NCT03669133 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 1807274844
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

NAFLD; NASH - Nonalcoholic Steatohepatitis; HIV Infections

Keywords

Fatty liver; NAFLD; NASH; HIV; Vitamin E

Outcome Measures

Primary Outcomes (1)

• 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

  at randomization visit (study day 1) and end of study visit (week 24)

Secondary Outcomes (3)

• Impact of Vitamin E Treatment on Noninvasive Markers of Hepatic Fibrosis

  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

  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

  Change in AST from study randomization (day 1) through the end of study visit (week 24)

Study Arms (2)

Group A

ACTIVE COMPARATOR

Vitamin E 800 IU/daily for 24 weeks

Drug: Vitamin E

Group B

PLACEBO COMPARATOR

Matching placebo for 24 weeks

Drug: Placebo

Interventions

Vitamin E DRUG

Vitamin E 800 IU/daily

Group A

Placebo DRUG

Matching placebo daily

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females ≥18 years with biopsy-proven NASH within 6 months prior to enrollment
• histological diagnosis of NASH will be confirmed by an experienced liver pathologist before study entry
• HIV infection
• 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
• willingness to participate in the study
• ability to understand and give informed consent for participation

You may not qualify if:

• Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilson disease, hemochromatosis, etc.)
• average alcohol consumption \>3 drinks/day for men or \>2 drinks/day for women in the 6 months prior to enrollment.
• Alcohol Use Disorder Identification Test (AUDIT) score of ≥8
• evidence of cirrhosis on histology or imaging
• 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)
• prior bariatric surgery
• severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness)
• allergy to vitamin E
• use of vitamin E or multivitamins containing vitamin E in the three months preceding enrollment
• 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.
• changing doses of statins (simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, fenofibrate) in the three months prior enrollment.
• illicit substance abuse within the past twelve months
• breast feeding, pregnancy, inability or unwillingness to practice contraception for the duration of the study
• contraindications for the MRI procedure (e.g., prostheses, severe claustrophobia)
• poorly controlled diabetes with A1C \>8.5 within in the last six months

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (2)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; HIV Infections; Fatty Liver

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Regina Weber
• Organization: Indiana University

reginaw@iu.edu

317-278-3584

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study biostatistician and Investigational Drug Services pharmacist will randomize subjects and will provide study drug
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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)

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 13, 2018
• Study Start: October 1, 2019
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)