Status:
COMPLETED
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Lead Sponsor:
Tufts University
Conditions:
Cardiovascular Disease
HIV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Detailed 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 H...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00795717
Start Date
July 1 2008
End Date
October 1 2010
Last Update
September 11 2019
Active Locations (1)
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1
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111