Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00575757
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00575757
Study Brief:
Protocol Section:
NCT00575757