The Impact of Omega Three Fatty Acids on Vascular Function in HIV

NCT01041521 | Completed Phase 4 Results DMC

• 2 other identifiers: LVZ1126671R01HL096585-01A1
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to determine if the use of omega three fatty acids in individuals infected with HIV and with high triglycerides leads to improved triglyceride levels, better blood vessel function and decrease in the amount of obstruction in blood vessels.

Conditions

High Triglyceride Level; HIV Infection

Keywords

HIV infection; Dyslipidemia; Elevated Triglyceride level; vascular function (BART); arterial stiffness; omega three fatty acids; complementary therapies

Outcome Measures

Primary Outcomes (1)

• Triglyceride Level

  24 months

Secondary Outcomes (1)

• Vascular Function

  24 months

Study Arms (2)

Lovaza (omega three fatty acid)

EXPERIMENTAL

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. Other Names: Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules

Drug: Lovaza

sugar pill

NO INTERVENTION

Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill

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 24 months

Also known as: omega three fatty acids, previously known as Omacor

Lovaza (omega three fatty acid)

Eligibility Criteria

• Age: 18 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 the previous two months and without anticipated changes in their HAART regimen throughout the duration of the study,
• Fasting triglycerides \> 150 mg/dl and \< 2,500 mg/dl
• Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changed during the course of the study.
• Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), and Estrogens (e.g., Estinyl; Estrace; Estraderm), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on 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 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 copies/ml
• change in HAART regimen over two months prior to study entry
• change in lipid lowering therapy within 2 months (8 weeks)
• Pregnancy in female participants
• Evidence of liver or renal disease with values of liver enzymes \> 5 X upper limit of normal or creatinine \> 1.5 X upper limit of normal
• presence of active opportunistic infection or malignancy
• presence of other inflammatory or end organ disease (, rheumatoid arthritis, active treatment for hepatitis c, or other diseases that may alter inflammatory markers)
• routine ingestion of fish oil (individuals who have used fish oil would be reconsidered for study participation if they discontinue use of fish oil for 8 weeks and TG levels remain elevated).
• Allergic to fish or Lovaza
• BMI \>35

Sponsors & Collaborators

• Tufts University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

HIV Infections; Dyslipidemias

Interventions

Omacor

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; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

PLEASE NOTE THAT THE PRINCIPLE INVESTIGATOR (CHRISTINE WANKE) HAS LEFT TUFTS UNIVERSITY IN RETIREMENT AND CANNOT BE CONTACTED. PLEASE ALSO NOTE THAT THIS IS NOT AN "APPLICABLE CLINICAL TRIAL". - 9/3/19

Results Point of Contact

• Title: Christine Wanke, Principal Investigator
• Organization: Tufts University

christine.wanke@tufts.edu

Study Officials

• Christine A Wanke, MD

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2009
• First Posted: December 31, 2009
• Study Start: January 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-02

Locations

US (1)