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Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Todd Conley, Tufts University
ClinicalTrials.gov Identifier:
NCT00795717
First received: November 19, 2008
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 ]

Enrollment: 41
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lovasa 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.
Other Name: Lovasa was previously known as Omacor (omega-3-acid ethyl esters) capsules
Placebo Comparator: sugar pill 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 without anticipated changes in their HAART regimen throughout the duration of the study
  • Fasting triglycerides > 150 mg/dl and < 1,500 mg/dl
  • Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be 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 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
  • 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

Locations
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Todd Conley
Investigators
Principal Investigator: Christine A Wanke, MD Tufts University School of Medicine
  More Information

No publications provided

Responsible Party: Todd Conley, Associate Director, Office of Research Administration, Tufts University
ClinicalTrials.gov Identifier: NCT00795717     History of Changes
Other Study ID Numbers: LVZ111888, 011293-GSK Contract Reference#
Study First Received: November 19, 2008
Last Updated: November 17, 2011
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013