The Impact of Omega Three Fatty Acids on Vascular Function in HIV (HOST)

Tracking Information
First Submitted Date ICMJE	December 30, 2009
First Posted Date ICMJE	December 31, 2009
Last Update Posted Date	December 15, 2016
Study Start Date ICMJE	January 2010
Actual Primary Completion Date	August 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 30, 2009)	triglyceride level [ Time Frame: 24 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01041521 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 27, 2012)	vascular function [ Time Frame: 6 months and 24 months ]
Original Secondary Outcome Measures ICMJE; (submitted: December 30, 2009)	vascular function [ Time Frame: 6 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Impact of Omega Three Fatty Acids on Vascular Function in HIV
Official Title ICMJE	The Impact of Omega Three Fatty Acids on Vascular Function in HIV
Brief Summary	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	High Triglyceride Level; HIV Infection
Intervention ICMJE	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: omega three fatty acids; previously known as Omacor
Study Arms	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 Intervention: Drug: Lovaza; No Intervention: sugar pill Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 14, 2016)	129
Original Estimated Enrollment ICMJE; (submitted: December 30, 2009)	150
Actual Study Completion Date	August 2015
Actual Primary Completion Date	August 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01041521
Other Study ID Numbers ICMJE	LVZ112667; 1R01HL096585-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Christine A. Wanke, Tufts University
Study Sponsor ICMJE	Christine A. Wanke
Collaborators ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Investigators ICMJE	Principal Investigator: Christine A Wanke, MD Tufts University
PRS Account	Tufts University
Verification Date	December 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP