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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) Reliant Pharmaceuticals National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00346697 |
The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation.
Condition | Intervention | Phase |
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HIV Infections AIDS Dyslipidemia Hypertriglyceridemia |
Procedure: Omega-3 fatty acid administration |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of N-3 Fatty Acid on Plasma Triglyceride Levels in Hypertriglyceridemic HIV Patients Receiving Highly Active Antiretroviral Therapy |
Estimated Enrollment: | 48 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2010 |
Hypertriglyceridemia is common among HIV-infected patients receiving Highly Active Antiretroviral Therapy (HAART). Although fibrates, statins, and niacin have all been used in the management of hypertriglyceridemia in HIV-infected patients, optimal control is difficult to achieve and other agents are needed. Omega-3 fatty acids are effective for lowering triglycerides in patients without HIV infection, but experience in HIV-infected patients is limited. In addition, omega-3 fatty acids may also have secondary benefits in decreasing bone resorption and decreasing markers of systemic inflammation.
The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation. It is 8- week randomized, double-blind trial of omega-3 fatty acids (OMACOR, Reliant, Inc) compared to placebo in 48 HAART-treated HIV-infected patients with triglycerides between 250 and 1000 mg/dl receiving dietary counseling. Subjects will be recruited from two centers (Johns Hopkins and Los Angeles VAMC). The primary endpoint will be the change in triglyceride concentrations from baseline in the OMACOR group compared to the placebo group. Secondary endpoints include the effect of OMACOR on other lipid targets (total cholesterol, LDL cholesterol, HDL-cholesterol), markers of systemic inflammation, markers of bone turnover, markers of insulin resistance, HIV-disease control (CD4+ counts, HIV viral loads), measures of hepatotoxicity (ALT), platelet function, and patient reports of adverse events. Omega-3 fatty acids may be a useful adjunct in the treatment of hypertriglyceridemia in HIV-infected patients, but additional controlled studies are needed to assess its safety and efficacy using a purified, standardized preparation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contact: Todd T. Brown, MD | 410-955-2130 | tbrown27@jhmi.edu |
United States, California | |
Veterans Administration of Greater Los Angeles Health System | Recruiting |
Los Angeles, California, United States, 90073 | |
Contact: David Leaf, MD 310-478-3711 David.Leaf@va.gov | |
Sub-Investigator: Matthew Goetz, MD | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Todd T Brown, MD 410-955-2130 tbrown27@jhmi.edu | |
Principal Investigator: Todd T Brown, MD | |
Sub-Investigator: Adrian S Dobs, MD |
Principal Investigator: | Todd T. Brown, MD | Johns Hopkins University |
Principal Investigator: | David Leaf, MD | Veterans Adminstration of Greater Los Angeles Health System |
Principal Investigator: | Mattew Goetz, MD | Veterans Adminstration of Greater Los Angeles Health System |
Principal Investigator: | Adrian S Dobs, MD | Johns Hopkins University |
Study ID Numbers: | K23 AT002862-01 |
Study First Received: | June 29, 2006 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00346697 History of Changes |
Health Authority: | United States: Federal Government |
AIDS HIV HAART Lipids Triglycerides |
Cholesterol omega-3 fatty acids bone turnover inflammation insulin resistance |
Sexually Transmitted Diseases, Viral Hypertriglyceridemia Hyperlipidemias Metabolic Diseases Acquired Immunodeficiency Syndrome Insulin Immunologic Deficiency Syndromes Inflammation |
Virus Diseases HIV Infections Sexually Transmitted Diseases Insulin Resistance Metabolic Disorder Retroviridae Infections Dyslipidemias Lipid Metabolism Disorders |
RNA Virus Infections Sexually Transmitted Diseases, Viral Metabolic Diseases Hyperlipidemias Slow Virus Diseases Hypertriglyceridemia Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Dyslipidemias Lipid Metabolism Disorders |