Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV

Completed · Not applicable

Conditions studied: Insulin Resistance, Cardiovascular Diseases, Heart Diseases, HIV Infections, Hypertriglyceridemia, Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT00246402

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

30

Starts

2002-09-01

Expected to finish

2006-08-01

Last updated by the study team

2014-05-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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