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

NCT00795717 | Completed Phase 4 Results DMC

• 2 other identifiers: LVZ111888011293-GSK Contract Reference#
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; HIV Infection

Keywords

HIV; cardiovascular risk; atherogenic lipid profile; brachial artery reactivity; omega three fatty acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Serum HDL Level

  12 weeks

• Brachial Artery Reactivity

  12 weeks

Study Arms (2)

Lovaza

ACTIVE COMPARATOR

Lovaza, dietary counseling

Drug: Lovaza

Placebo

PLACEBO COMPARATOR

Placebo, dietary counseling

Drug: Placebo

Interventions

Lovaza DRUG

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.

Also known as: Omacor (omega-3-acid ethyl esters) capsules

Lovaza

Placebo DRUG

2 capsules given twice daily

Also known as: corn oil

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 24988179 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; HIV Infections

Interventions

Omacor; Capsules; Corn Oil

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

We had low numbers that may not represent the overall population. There was not an HIV negative control arm. The 4 week wash out was too short and therefore difficult to compare the post-treatment vs true post placebo effects.

Results Point of Contact

• Title: Christine A. Wanke, MD
• Organization: Tufts University School of Medicine

christine.wanke@tufts.edu

617-636-3811

Study Officials

• Christine A Wanke, MD

  Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 21, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 11, 2019
• Results First Posted: December 8, 2014

Record last verified: 2019-08

Locations

US (1)