Relationship of Metabolic Abnormalities to Hepatic Steatosis in HIV
2 other identifiers
observational
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 14, 2007
CompletedFirst Posted
Study publicly available on registry
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 18, 2016
August 1, 2016
9 years
December 14, 2007
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
What is the spectrum of NAFLD in HIV
2 years
Secondary Outcomes (2)
How does the spectrum compare in those that are on a PI compare to those that are not.
2 years
What are the independent predictive factors associated with hepatic steatosis and NASH?
2 years
Study Arms (1)
Primary
HIV infected with abnormal liver enzymes in the absence of HCV or HBV coinfections.
Eligibility Criteria
HIV positive with abnormal liver enzymes in the absence of HCV/HBV coinfections.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virgnia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (1)
Sterling RK, Smith PG, Brunt EM. Hepatic steatosis in human immunodeficiency virus: a prospective study in patients without viral hepatitis, diabetes, or alcohol abuse. J Clin Gastroenterol. 2013 Feb;47(2):182-7. doi: 10.1097/MCG.0b013e318264181d.
PMID: 23059409DERIVED
Biospecimen
sera, liver tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard K Sterling, MD MSc
VCU
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2007
First Posted
December 18, 2007
Study Start
July 1, 2007
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
August 18, 2016
Record last verified: 2016-08