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

Sponsor:	Brown, Todd, M.D., Ph.D.
Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) GlaxoSmithKline National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Brown, Todd, M.D., Ph.D.
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	Drug: Omega-3 fatty acid administration	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Cholesterol Diabetes Medicines HIV/AIDS Triglycerides

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by Brown, Todd, M.D., Ph.D.:

Primary Outcome Measures:

Change in triglyceride concentrations from baseline in the LOVAZA group compared to the placebo group. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
LDL cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
HDL-cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Markers of systemic inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Markers of insulin resistance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
HIV-disease control (CD4+ counts, HIV viral loads) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Measures of hepatotoxicity (ALT) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Platelet function [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
Experimental: LOVAZA 4 g/d of omega-3 fatty acid esters, plus dietary counseling	Drug: Omega-3 fatty acid administration LOVAZA 1 gram capsules, 4 capsules daily
Placebo Comparator: Placebo Corn oil placebo, plus dietary counselling	Drug: Omega-3 fatty acid administration LOVAZA 1 gram capsules, 4 capsules daily

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 (LOVAZA, GSK, 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 three centers (Johns Hopkins, Georgetown, and Los Angeles VAMC). The primary endpoint will be the change in triglyceride concentrations from baseline in the LOVAZA group compared to the placebo group. Secondary endpoints include the effect of LOVAZA 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 200 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 > 4.5)
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	Active, not recruiting
Los Angeles, California, United States, 90073
United States, District of Columbia
Georgetown University	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Joseph Timpone, MD 202-687-6845 timponej@gunet.georgetown.edu
United States, Maryland
Johns Hopkins University	Active, not recruiting
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Brown, Todd, M.D., Ph.D.

National Center for Complementary and Alternative Medicine (NCCAM)

GlaxoSmithKline

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
Principal Investigator:	Joseph Timpone, MD	Georgetown University

More Information

No publications provided

Responsible Party:	Todd T. Brown, MD, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00346697 History of Changes
Other Study ID Numbers:	K23 AT002862-01, K23AT002862-01
Study First Received:	June 29, 2006
Last Updated:	February 16, 2010
Health Authority:	United States: Federal Government

Keywords provided by Brown, Todd, M.D., Ph.D.:

AIDS
HIV
HAART
Lipids
Triglycerides

Cholesterol
omega-3 fatty acids
bone turnover
inflammation
insulin resistance

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Hypertriglyceridemia
Dyslipidemias
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on February 09, 2012