Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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 antiretroviral therapy (HAART) associated metabolic disturbances.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Acipimox

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