Relationship of Metabolic Abnormalities to Hepatic Steatosis in HIV

Completed

Conditions studied: Steatohepatitis

In brief

Because NASH is now recognized as a significant cause of cirrhosis with associated morbidity and mortality, its recognition as a long term complication of HAART is important to the management of those living with HIV.

Key facts

Study ID

NCT00575757

Run by

Virginia Commonwealth University

People needed

12

Starts

2007-07-01

Expected to finish

2016-07-01

Last updated by the study team

2016-08-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV antibody positive.
• Age > 18 years
• Abnormal liver chemistries (AST, ALT, and/or ALP) defined as between 1.25 -5 x ULN.

You may not qualify if…

• Hepatic decompensation: coagulopathy (prothrombin time prolonged > 2 seconds, INR > 1.5), ascites, hepatic encephalopathy, jaundice (serum conjugated bilirubin > 3.0)
• Thrombocytopenia (platelets < 80,000)
• Use of vitamin E, thiazolidinediones, metformin
• Use of medications associated with steatosis: amiodarone, methotrexate, corticosteroids, estrogen, and tamoxifen
• Renal failure (serum creatinine > 3.0)
• Diabetes mellitus
• Advanced HIV disease with life expectancy less than 1 year
• Alcohol use (> 40 grams/day in men and 20 grams/day in women)
• Presence of HCV RNA or HBV surface antigen
• Other liver diseases including alpha-1 antitrypsin (A1AT) deficiency, autoimmune hepatitis, hemochromatosis, Wilson's disease, HIV cholangiopathy, bacillary angiomatosis, lymphoma, and Kaposi's sarcoma
• Inability to give informed consent.

Where it is running

• Virgnia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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