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:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT00246402
Eligibility Criteria:
Inclusion Criteria:
* Documented HIV infection
* Stable antiretroviral regimen for greater than 3 months
* Hypertriglyceridemia (fasting triglycerides greater than 150mg/dl)
* Evidence of fat redistribution (e.g., increased abdominal or cervical fat, and/or decreased subcutaneous fat of the face, arms, or legs) on physical exam
Exclusion Criteria:
* Current therapy with a lipid lowering medication (e.g., fibrates, HMG CoA reductase inhibitors, resins) or treatment with these agents in the 3 months prior to study entry
* Current use of hormone replacement therapy, oral contraceptives for women, or supraphysiologic testosterone therapy in men
* Fasting triglycerides greater than 1000mg/dl
* Active alcohol or substance abuse
* Active peptic ulcer disease
* History of renal failure or serum creatinine greater than 2.0
* Serious opportunistic infection within the 3 months prior to study entry
* Hemoglobin less than 11.0 mg/dl
* Elevated transaminase levels (AST or ALT greater than 2.5x the upper limit of normal)
* Previously diagnosed diabetes mellitus or patients receiving current treatment for diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00246402
Study Brief:
Protocol Section:
NCT00246402