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

Completed · Phase 4 · Has a placebo group

Conditions studied: Cardiovascular Disease, HIV Infection

In brief

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.

Key facts

Study ID

NCT00795717

Run by

Tufts University

People needed

41

Starts

2008-07-01

Expected to finish

2010-10-01

Last updated by the study team

2019-09-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tufts University School of Medicine — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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