Overview

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