The Impact of Omega Three Fatty Acids on Vascular Function in HIV (HOST)
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The study seeks to determine if the use of omega three fatty acids in individuals infected with HIV and with high triglycerides leads to improved triglyceride levels, better blood vessel function and decrease in the amount of obstruction in blood vessels.
Condition | Intervention | Phase |
---|---|---|
High Triglyceride Level HIV Infection |
Drug: Lovaza |
Phase 4 |
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: | The Impact of Omega Three Fatty Acids on Vascular Function in HIV |
- triglyceride level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- vascular function [ Time Frame: 6 months and 24 months ] [ Designated as safety issue: No ]
Estimated Enrollment: | 150 |
Study Start Date: | January 2010 |
Estimated Study Completion Date: | January 2015 |
Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Lovaza (omega three fatty acid)
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks. Other Names: Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules |
Drug: Lovaza
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
Other Names:
|
No Intervention: sugar pill
Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill |
Detailed Description:
While omega-three fatty acids have been shown to be beneficial for TG and HDL-C levels in HIV uninfected individuals and in some small, short duration studies in HIV-infected individuals, there are no data that extend these observations to determine whether intake of omega-three fats over a more prolonged time period will also have a beneficial impact on functional outcomes such as vascular endothelial function and anatomic surrogate markers of CVD in HIV-infected patients.
We propose a randomized, double blind trial of purified omega-three fatty acids in HIV-infected individuals with elevated levels of triglycerides. While the impact of omega-three fatty acids on lipid profiles should be evident early (within 12 weeks); we propose to conduct this trial for a full 24 months to test our overall hypothesis that this intervention will not only improve triglyceride and HDL-C levels, improve HDL-subpopulations, plasma and membrane phospholipids and decrease inflammation, but will also improve brachial artery reactivity testing (BART) as a measure of vascular endothelial function at 24 weeks and 24 months and arterial stiffness measured by a pulse wave velocity test as a surrogate marker of CVD risk at 24 months when compared to controls.
The specific aims of this proposal include:
- To conduct a randomized, placebo controlled trial of omega-three fatty acids over 24 months in HIV-infected individuals with elevated levels of triglycerides (> 150 mg/dl).
- To demonstrate the impact of omega-three fatty acid intake on TG levels and on HDL-C levels, HDL subpopulations, composition of plasma and membrane phospholipids, and chronic inflammation as measured by CRP, sPLA2 and by levels of arachidonic acid.
- To demonstrate the impact of omega-three fatty acid intake on BART at 24 weeks and 24 months and on arterial stiffness at 24 months.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-infected men and women at least 18 years of age,
- On stable HAART for the previous two months and without anticipated changes in their HAART regimen throughout the duration of the study,
- Fasting triglycerides > 150 mg/dl and < 2,500 mg/dl
- Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changed during the course of the study.
- Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), and Estrogens (e.g., Estinyl; Estrace; Estraderm), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke.
- Female participants of reproductive age must not be pregnant (negative test) or lactating at screening and throughout the trial and agree to use contraception for the course of the trial and 2 months after the trial unless they are surgically sterilized (tubal ligation or hysterectomy), or post-menopausal with no menses for > 1 year.
- Ability to provide consent.
Exclusion Criteria:
- plasma HIV-1 RNA > 10,000 copies/ml
- change in HAART regimen over two months prior to study entry
- change in lipid lowering therapy within 2 months (8 weeks)
- Pregnancy in female participants
- Evidence of liver or renal disease with values of liver enzymes > 5 X upper limit of normal or creatinine > 1.5 X upper limit of normal
- presence of active opportunistic infection or malignancy
- presence of other inflammatory or end organ disease (, rheumatoid arthritis, active treatment for hepatitis c, or other diseases that may alter inflammatory markers)
- routine ingestion of fish oil (individuals who have used fish oil would be reconsidered for study participation if they discontinue use of fish oil for 8 weeks and TG levels remain elevated).
- Allergic to fish or Lovaza
- BMI >35
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Contact: Jul Gerrior, RD | 617-636-3636 | jul.gerrior@tufts.edu |
United States, Massachusetts | |
Tufts University School of Medicine | Recruiting |
Boston, Massachusetts, United States, 02111 | |
Contact: Jul Gerrior, RD 617-636-3636 jul.gerrior@tufts.edu | |
Principal Investigator: Christine A Wanke, MD |
Principal Investigator: | Christine A Wanke, MD | Tufts University |
![](https://webarchive.library.unt.edu/web/20130305102255im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Todd Conley, Associate Director, Office of Research Administration, Tufts University |
ClinicalTrials.gov Identifier: | NCT01041521 History of Changes |
Other Study ID Numbers: | LVZ112667, 1R01HL096585-01A1 |
Study First Received: | December 30, 2009 |
Last Updated: | July 27, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tufts University:
HIV infection Dyslipidemia Elevated Triglyceride level vascular function (BART) |
arterial stiffness omega three fatty acids complementary therapies |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hypertriglyceridemia 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 Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2013