Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial - Full Text View

Sponsored by:	Tufts University
Information provided by:	Tufts University
ClinicalTrials.gov Identifier:	NCT00795717

Purpose

The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoprotiens (HDL), and an improvement of endothelial dysfunction.

Condition	Intervention	Phase
Cardiovascular Risk HIV Infection	Dietary Supplement: Lovaza Dietary Supplement: sugar pill	Phase IV

MedlinePlus related topics: AIDS Dietary Supplements

Drug Information available for: Omacor Lipids Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

Further study details as provided by Tufts University:

Primary Outcome Measures:

Serum Triglyceride Level [ Time Frame: 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum HDL level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Brachial Artery Reactivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lovasa: Active Comparator	Dietary Supplement: 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 12 weeks.
sugar pill: Placebo Comparator	Dietary Supplement: sugar pill 2 capsules given twice daily

Detailed Description:

This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, with 12-week treatment periods separated by a 4-week washout. This study will be conducted at the Clinical Research Center at Tufts Medical Center.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-infected men and women at least 18 years of age
On stable HAART for previous three months and whithout anticipated changes in their HAART regimen throughout the duration of the study
Fasting triglycerides > 150 mg/dl and < 1,500 mg/dl
Particpants may be on lipid lowering therapty; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changes during the course of the study
Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on the 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 2 methods of barrier contraception for the course of teh trial and 2 months after the trial unless they are sugically 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
Previous history of atherosclerotic disease or diabetes mellitus
Change in HAART regimen over three months prior to study entry
Change in lipid lowering therapy within 2 months
On chronic anticoagulants such as heparin or coumadin
On fish oil, omega 3 supplements, or Omacor currently or during the past month

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795717

Contacts

Contact: Christine A Wanke, MD

617-636-0921

christine.wanke@tufts.edu

Locations

United States, Massachusetts
Tufts University School of Medicine	Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Christine A Wanke, MD

Sponsors and Collaborators

Tufts University

Investigators

Principal Investigator:

Christine A Wanke, MD

Tufts University School of Medicine

More Information

Responsible Party:	Tufts University School of Medicine ( Christine A. Wanke )
Study ID Numbers:	LVZ111888, 011293-GSK Contract Reference#
Study First Received:	November 19, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795717
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tufts University:

HIV
cardiovascular risk
atherogenic lipid profile
brachial artery reactivity
omega three fatty acids

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009