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

Primary Purpose

HIV Infections, AIDS, Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acid administration
Placebo
Sponsored by
Brown, Todd, M.D., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring AIDS, HIV, HAART, Lipids, Triglycerides, Cholesterol, omega-3 fatty acids, bone turnover, inflammation, insulin resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Administration of Greater Los Angeles Health System
  • Georgetown University
  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LOVAZA

Placebo

Arm Description

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

Corn oil placebo, plus dietary counselling

Outcomes

Primary Outcome Measures

Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2006
Last Updated
November 4, 2014
Sponsor
Brown, Todd, M.D., Ph.D.
Collaborators
National Center for Complementary and Integrative Health (NCCIH), GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00346697
Brief Title
Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown, Todd, M.D., Ph.D.
Collaborators
National Center for Complementary and Integrative Health (NCCIH), GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, AIDS, Dyslipidemia, Hypertriglyceridemia
Keywords
AIDS, HIV, HAART, Lipids, Triglycerides, Cholesterol, omega-3 fatty acids, bone turnover, inflammation, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LOVAZA
Arm Type
Experimental
Arm Description
4 g/d of omega-3 fatty acid esters, plus dietary counseling
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Corn oil placebo, plus dietary counselling
Intervention Type
Drug
Intervention Name(s)
Omega-3 fatty acid administration
Intervention Description
LOVAZA 1 gram capsules, 4 capsules daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Corn-oil placebo
Primary Outcome Measure Information:
Title
Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame
8 weeks
Title
Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame
8 weeks
Title
Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame
8 weeks
Title
Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame
8 weeks
Title
Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group
Time Frame
8 weeks
Title
Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Title
Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Title
Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Title
Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Title
Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Title
Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Title
Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Title
Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks
Title
Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd T. Brown, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Leaf, MD
Organizational Affiliation
Veterans Adminstration of Greater Los Angeles Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mattew Goetz, MD
Organizational Affiliation
Veterans Adminstration of Greater Los Angeles Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrian S Dobs, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Timpone, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Administration of Greater Los Angeles Health System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23683266
Citation
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.
Results Reference
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Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients

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