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

Cardiovascular Disease Clinical Trial

— HALO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795717
• Other study ID #: LVZ111888
• Secondary ID: 011293-GSK Contr
• Status: Completed
• Phase: Phase 4
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2019
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cardiovascular Disease
• Cardiovascular Diseases
• HIV Infection
• HIV Infections

Intervention

Drug:
• 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.
• Placebo
2 capsules given twice daily

Locations

Country	Name	City	State
United States	Tufts University School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline Mean Serum Triglyceride Level at Study End	Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo	Baseline and 12 weeks
Secondary	Serum HDL Level		12 weeks
Secondary	Brachial Artery Reactivity	To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.; Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of "% of brachial artery".	12 weeks