Vitamin E for NASH Treatment in HIV Infected Individuals
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Study biostatistician and Investigational Drug Services pharmacist will randomize subjects and will provide study drug
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •use of total parenteral nutrition in the 6 months preceding liver biopsy or enrollment
研究组 & 干预措施
Group A
Vitamin E 800 IU/daily for 24 weeks
干预措施: Vitamin E (Drug)
Group B
Matching placebo for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction
时间窗: at randomization visit (study day 1) and end of study visit (week 24)
change in liver steatosis via MRI-PDFF at randomization (day 1) and study completion (week 24) to assess liver steatosis
次要结局
- 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))
研究者
Samer Gawrieh
Associate Professor of Medicine
Indiana University School of Medicine