Clinical trial NCT00795717: Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Official title: Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
HIV Infection
Keywords: HIV
cardiovascular risk
atherogenic lipid profile
brachial artery reactivity
omega three fatty acids
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 density lipoproteins(HDL), and an improvement of endothelial dysfunction.

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 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.

Eligibility 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

Primary outcomes:
measure: Change in Baseline Mean Serum Triglyceride Level at Study End
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Serum HDL Level
timeFrame: 12 weeks
measure: Brachial Artery Reactivity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Medicine
name: Christine A Wanke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paranandi A, Asztalos BF, Mangili A, Kuvin J, Gerrior J, Sheehan H, Skinner SC, Tang AM, Wanke CA. Short communication: effects of omega-3 fatty acids on triglycerides and high-density lipoprotein subprofiles in HIV-infected persons with hypertriglyceridemia. AIDS Res Hum Retroviruses. 2014 Aug;30(8):800-5. doi: 10.1089/AID.2014.0005.