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

NCT ID: NCT00346697

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-04-30

Brief Summary

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.

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.

Conditions

HIV Infections; AIDS; Dyslipidemia; Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LOVAZA

4 g/d of omega-3 fatty acid esters, plus dietary counseling

Group Type: EXPERIMENTAL

Omega-3 fatty acid administration

Intervention Type: DRUG

LOVAZA 1 gram capsules, 4 capsules daily

Placebo

Corn oil placebo, plus dietary counselling

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Corn-oil placebo

Interventions

Omega-3 fatty acid administration

LOVAZA 1 gram capsules, 4 capsules daily

Intervention Type: DRUG

Placebo

Corn-oil placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

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

INDIV

Sponsor Role: lead

Responsible Party

Todd T. Brown, MD, PhD

Associate Professor of Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todd T. Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

David Leaf, MD

Role: PRINCIPAL_INVESTIGATOR

Veterans Adminstration of Greater Los Angeles Health System

Mattew Goetz, MD

Role: PRINCIPAL_INVESTIGATOR

Veterans Adminstration of Greater Los Angeles Health System

Adrian S Dobs, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Joseph Timpone, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Veterans Administration of Greater Los Angeles Health System

Los Angeles, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

References

Metkus TS, Timpone J, Leaf D, Bidwell Goetz M, Harris WS, Brown TT. Omega-3 fatty acid therapy reduces triglycerides and interleukin-6 in hypertriglyeridemic HIV patients. HIV Med. 2013 Oct;14(9):530-9. doi: 10.1111/hiv.12046. Epub 2013 May 19.

Reference Type: RESULT

PMID: 23683266 (View on PubMed)

Other Identifiers

K23AT002862-01

Identifier Type: NIH

Identifier Source: secondary_id

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K23AT002862-01

Identifier Type: NIH

Identifier Source: org_study_id

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