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

Tufts University

Status and phase: Completed; Phase 4

Conditions: HIV Infection; Cardiovascular Disease

Treatments: Drug: Lovaza; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00795717

LVZ111888

011293-GSK Contract Reference#

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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41 participants in 2 patient groups, including a placebo group

Lovaza

Active Comparator group

Description:

Lovaza, dietary counseling

Treatment:

Drug: Lovaza

Placebo

Placebo Comparator group

Description:

Placebo, dietary counseling

Treatment:

Drug: Placebo