Relationship of Metabolic Abnormalities to Hepatic Steatosis in HIV
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00575757 |
Recruitment Status
:
Completed
First Posted
: December 18, 2007
Last Update Posted
: August 18, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Steatohepatitis |
Study Type : | Observational |
Actual Enrollment : | 12 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Relationship of Metabolic Abnormalities to Hepatic Steatosis in HIV |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Group/Cohort |
---|
Primary
HIV infected with abnormal liver enzymes in the absence of HCV or HBV coinfections.
|
- What is the spectrum of NAFLD in HIV [ Time Frame: 2 years ]
- How does the spectrum compare in those that are on a PI compare to those that are not. [ Time Frame: 2 years ]
- What are the independent predictive factors associated with hepatic steatosis and NASH? [ Time Frame: 2 years ]
Biospecimen Retention: Samples Without DNA

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.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV antibody positive.
- Age > 18 years
- Abnormal liver chemistries (AST, ALT, and/or ALP) defined as between 1.25 -5 x ULN.
Exclusion Criteria:
- 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.

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): NCT00575757
United States, Virginia | |
Virgnia Commonwealth University | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Richard K Sterling, MD MSc | VCU |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00575757 History of Changes |
Other Study ID Numbers: |
VCUHM10107 1R03DK075416-01 ( U.S. NIH Grant/Contract ) |
First Posted: | December 18, 2007 Key Record Dates |
Last Update Posted: | August 18, 2016 |
Last Verified: | August 2016 |
Keywords provided by Virginia Commonwealth University:
Steatosis NASH |
Additional relevant MeSH terms:
Fatty Liver Liver Diseases Digestive System Diseases |