Status:
COMPLETED
Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Insulin Resistance
Cardiovascular Diseases
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to test whether chronic administration of the drug acipimox will improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing highly active anti...
Detailed Description
BACKGROUND: HIV infected patients treated with HAART are at increased risk for developing significant dyslipidemia, insulin resistance, and abnormal patterns of fat distribution. While the exact mech...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00246402
Start Date
September 1 2002
End Date
August 1 2006
Last Update
May 15 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114