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

November 4, 2014 updated by: Todd T. Brown, MD, PhD, Brown, Todd, M.D., Ph.D.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • Veterans Administration of Greater Los Angeles Health System
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Placebo
Corn-oil placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame: 8 weeks
8 weeks
Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame: 8 weeks
8 weeks
Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame: 8 weeks
8 weeks
Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame: 8 weeks
8 weeks
Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame: 8 weeks
8 weeks
Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks
Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks
Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks
Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks
Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks
Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks
Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks
Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks
Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

GlaxoSmithKline
National Center for Complementary and Integrative Health (NCCIH)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (ESTIMATE)

June 30, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23AT002862-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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