Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV

NCT00246402 | Completed

• 2 other identifiers: 337R21HL073675
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Cardiovascular Diseases; Heart Diseases; HIV Infections; Hypertriglyceridemia; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Fasting Triglyceride Concentration (Initial, after 3 months)

Secondary Outcomes (1)

• Insulin Sensitivity (Initial, after 3 months)

Interventions

Acipimox DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Hadigan C, Liebau J, Torriani M, Andersen R, Grinspoon S. Improved triglycerides and insulin sensitivity with 3 months of acipimox in human immunodeficiency virus-infected patients with hypertriglyceridemia. J Clin Endocrinol Metab. 2006 Nov;91(11):4438-44. doi: 10.1210/jc.2006-1174. Epub 2006 Aug 29.

  PMID: 16940448 RESULT

MeSH Terms

Conditions

Insulin Resistance; Cardiovascular Diseases; Heart Diseases; HIV Infections; Hypertriglyceridemia; Hyperlipidemias

Interventions

acipimox

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Colleen M. Hadigan, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: September 1, 2002
• Study Completion: August 1, 2006
• Last Updated: May 15, 2014

Record last verified: 2007-12

Locations

US (1)