Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV (NCT00246402) | Clinical Trial Compass
CompletedNot Applicable
Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV
United States30 participantsStarted 2002-09
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Fasting Triglyceride Concentration (Initial, after 3 months)
Trial details
NCT IDNCT00246402
SponsorNational Heart, Lung, and Blood Institute (NHLBI)