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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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 lipoproteins(HDL), and an improvement of endothelial dysfunction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Todd Conley; Tufts University

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