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Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00246402
Recruitment Status : Completed
First Posted : October 30, 2005
Last Update Posted : May 15, 2014
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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 antiretroviral therapy (HAART) associated metabolic disturbances.

Condition or disease Intervention/treatment Phase
Insulin Resistance Cardiovascular Diseases Heart Diseases HIV Infections Hypertriglyceridemia Hyperlipidemia Drug: Acipimox Not Applicable

Detailed Description:


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 mechanism responsible for these changes is not known, there is increasing evidence that patients with HIV infection and fat redistribution have increased basal rates of lipolysis and elevated circulating free fatty acids (FFA). Patients with HIV associated lipodystrophy have increased FFA levels that correlated directly with impaired glucose metabolism and triglyceride concentrations. Furthermore, acute inhibition of lipolysis in patients with HIV lipodystrophy and insulin resistance results in improvement in insulin sensitivity. However, long-term administration of lipolytic blocking agents has not been evaluated in this patient population. Acipimox, a nicotinic acid analogue and a potent inhibitor of lipolysis, is an established therapy for dyslipidemia. In addition, through effects on lowering circulating FFA, acute administration of acipimox has been shown to improve insulin sensitivity in other populations, including lean and obese individuals and patients with type II diabetes. This study will test the hypothesis that chronic administration of acipimox will improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing HAART associated metabolic disturbances.


The study will be a 3-month double-blind placebo-controlled trial of 250 mg of acipimox three times daily in 30 patients with HAART lipodystrophy. The primary clinical endpoint of this study will be the change in fasting triglyceride concentration, comparing baseline values to those obtained after 3 months of acipimox or placebo. Insulin sensitivity, an important secondary endpoint, will be determined by hyperinsulinemic euglycemic clamp studies. Rates of lipolysis in the fasting state will be quantified by a 3-hour infusion of stable isotope-labeled glycerol. Indirect calorimetry will be used to assess changes in resting energy expenditure. Cross-sectional computed tomography (CT) imaging of the thigh and abdomen will allow for measurement of visceral and subcutaneous fat areas. Dual energy x-ray absorptiometry (DEXA) will be used to determine whole body fat mass.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Anti-Lipolytic Strategy for HIV Lipodystrophy
Study Start Date : September 2002
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Fasting Triglyceride Concentration (Initial, after 3 months)

Secondary Outcome Measures :
  1. Insulin Sensitivity (Initial, after 3 months)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00246402

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Colleen M. Hadigan, MD Massachusetts General Hospital

Publications of Results:
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Responsible Party: Colleen Hadigan, MD MPH, Harvard Medical School, Massachusetts General Hospital Identifier: NCT00246402    
Other Study ID Numbers: 337
R21HL073675 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2005    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: December 2007
Additional relevant MeSH terms:
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Heart Diseases
Insulin Resistance
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents