Omega-3 Fatty Acids for High Triglycerides in HIV-Infected Patients - Full Text View

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)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00346697

Purpose

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
HIV Infections AIDS Dyslipidemia Hypertriglyceridemia	Procedure: Omega-3 fatty acid administration	Phase IV

MedlinePlus related topics: AIDS Cholesterol Triglycerides

Drug Information available for: Insulin Cholest-5-en-3-ol (3beta)- Lipids

U.S. FDA Resources

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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Change in triglyceride concentrations from baseline in the OMACOR group compared to the placebo group.

Secondary Outcome Measures:

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

Estimated Enrollment:	48
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2010

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability and willingness to give informed consent
Age ≥ 18 years
HIV-1 infection documented at any time prior to study entry
Fasting plasma triglyceride value between 250 and 1000 mg/dL on two occasions within 4 weeks
Subjects must be receiving a stable antiretroviral medication regimen for > 3 months without any anticipated changes during the study interval
Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception
On stable lipid modification pharmacotherapy for at least 8 weeks prior to study entry

Exclusion Criteria

Hemoglobin A1C > 8.5 %
Uncontrolled hypothyroidism (TSH > 4)
HIV viral load > 5,000 copies/ml (cpm),
Active liver disease and/or liver transaminases greater than 2.0 X upper limit of normal
Active kidney disease or serum creatinine > 2.5 mg/dL
Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure
Uncontrolled hypertension within 4 weeks of study entry (SBP > 180 mmHg or DBP > 100 mmHg)
Use of systemic cancer chemotherapy within 8 weeks of study entry
Pregnancy or breastfeeding
Drug or alcohol dependence, or other conditions which may affect study compliance
History of coagulopathy or use of anticoagulants such as warfarin
Use of omega-3 fatty acid preparation in the 12 weeks prior to randomization
Significant changes in clinical status from the Screening Visit which would preclude the patient from being an appropriate candidate.
Any of the following laboratory parameters: hematocrit < 25%, absolute neutrophil count < 1.5 x 10^9/L, platelets < 100 x 10^9/L or hemoglobin < 8.0 gm/dL

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346697

Contacts

Contact: Todd T. Brown, MD

410-955-2130

tbrown27@jhmi.edu

Locations

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

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)

Investigators

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

More Information

Study ID Numbers:	K23 AT002862-01
Study First Received:	June 29, 2006
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00346697
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

AIDS
HIV
HAART
Lipids
Triglycerides

Cholesterol
omega-3 fatty acids
bone turnover
inflammation
insulin resistance

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009