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The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
This study has been completed.
First Received: January 26, 2004   Last Updated: September 15, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00076518
  Purpose

The purpose of this study is to determine the effectiveness of fish oil supplements combined with the drug fenofibrate in treating elevated triglyceride levels in people taking anti-HIV drugs. The participants in this study will have shown no response to fish oil supplements or fenofibrate alone.


Condition Intervention Phase
HIV Infections
Hypertriglyceridemia
Drug: Fenofibrate
Drug: Fish Oil
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of the Effect of Combination Therapy With Fish Oil Supplement and Fenofibrate on Triglyceride (TG) Levels in Subjects on Highly Active Antiretroviral Therapy (HAART) Who Are Not Responding to Either Fish Oil or Fenofibrate Alone

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 100
Detailed Description:

Although highly active antiretroviral therapy (HAART) has decreased the morbidity and mortality caused by HIV infection, its use has been associated with lipid abnormalities, particularly elevations in serum triglycerides. Hypertriglyceridemia is a risk factor in the development of cardiovascular and cerebrovascular disease as well as pancreatitis. Lipid-lowering drugs called fibrates have been part of the recommended treatment for elevated triglycerides, but the response to fibrates is incomplete in a large proportion of people. Fish oil capsules containing large amounts of omega-3 fatty acids have been shown to decrease serum triglycerides. However, fish oil supplements or fibrates alone are often inadequate for treating hypertriglyceridemia in people taking HAART. This study will determine whether the combination of the two therapies will lower serum triglycerides in people on HAART more effectively than either therapy alone.

This study comprises two steps. In Step I, participants will be randomly assigned to receive either fish oil supplements or fenofibrate. Participants will be evaluated for treatment response at Week 8. Those who have responded to their treatment will remain on their original single agent therapy through Week 18. Those who have not responded to treatment at Week 10 will move on to Step 2 and begin combination therapy with both fenofibrate and fish oil until Week 18. All participants will return at Week 22 for a follow-up visit. Except at the Week 10 visit, participants will be expected to fast prior to all study visits. Participants will remain on their individual HAART regimens for the duration of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected
  • Fasting LDL <= 160 mg/dL and fasting serum triglycerides >= 400 mg/dL within 28 days prior to study entry
  • Willing and able to adhere to a lipid-lowering diet and exercise program for at least 28 days prior to study start and for the duration of the study
  • Treatment with HAART for at least 3 months prior to study entry. Participants must be on stable HAART for at least 4 weeks immediately prior to study entry. Participants who have changed from a protease inhibitor (PI)-based regimen to a non-PI-based regimen in the previous 3 months must be on stable HAART for at least 8 weeks immediately prior to study entry.
  • Willingness to remain on current HAART regimen for the duration of the study
  • Women of reproductive potential must use an acceptable method of contraception while receiving study drugs and for at least 4 weeks after stopping the study drugs
  • Men on testosterone replacement therapy must have been on stable therapy for at least 3 months prior to study entry and must be willing to continue stable therapy for the duration of the study
  • Participants on hormone replacement therapy other than testosterone replacement therapy and participants using oral contraceptives must have been on stable therapy for at least 28 days prior to study entry and must be willing to continue stable therapy for the duration of the study

Exclusion Criteria:

  • Use of investigational antiretroviral drugs within 28 days prior to study entry. Investigational therapies allowed by the study chairs or given in an AACTG study or expanded access trial are permitted, as long as the treatment can be continued for the duration of this study.
  • Coronary heart disease
  • Atherosclerotic disease risk
  • Congestive heart failure
  • Uncontrolled hypertension within 28 days prior to study entry
  • Active bleeding disorder or active peptic ulcer disease
  • Diabetes mellitus that requires pharmacological, dietary control, or diabetic medication within 28 days prior to study entry
  • Untreated hypothyroidism. Participants who are currently being treated for hypothyroidism are not excluded if the treatment was initiated at least 28 days prior to study entry.
  • Use of levothyroxine or liothyronine, except for treatment of hypothyroidism, within 90 days prior to study entry.
  • Active or symptomatic gallbladder disease within 1 year prior to study entry
  • Use of systemic cancer chemotherapy within 60 days prior to study entry
  • Cancer within 5 years prior to study entry. Skin cancers not requiring systemic treatment are allowed.
  • Pregnancy or breast-feeding
  • Use of any lipid-lowering agent within 28 days prior to study entry
  • Use of hormonal anabolic therapies within 6 months prior to study entry
  • Use of systemic steroids
  • Use of immune modulators within 28 days prior to study entry
  • Use of anticoagulants within 14 days prior to study entry
  • Allergy or sensitivity to study drugs or their formulations
  • Active drug or alcohol use or dependence that would interfere with adherence to study requirements
  • Decreased mental capacity that would interfere with adherence to study requirements
  • Active AIDS-defining opportunistic infection (OI) within 28 days prior to study entry. Participants who have no evidence of active disease and are receiving maintenance therapy for AIDS-related OIs will be eligible.
  • Any acute illness within 28 days prior to study entry that would interfere with participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076518

  Hide Study Locations
Locations
United States, California
Stanford University
Stanford, California, United States, 94305-5107
San Mateo County AIDS Program
Stanford, California, United States, 94305-5107
Willow Clinic
Stanford, California, United States, 94305-5107
UCLA School of Medicine
Los Angeles, California, United States, 90095-1793
San Francisco General Hospital
San Francisco, California, United States, 94110
University of California, San Diego Antiviral Rese
San Diego, California, United States, 92103
United States, Florida
University of Miami
Miami, Florida, United States, 33136-1013
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96816-2396
United States, Illinois
Cook County Hospital Core Center
Chicago,, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611-3015
United States, Indiana
Methodist Hospital of Indiana
Indianapolis, Indiana, United States, 46202-5250
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242-1201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455-0392
United States, Missouri
Washington University (St. Louis)
St. Louis, Missouri, United States, 63108-2138
United States, Nebraska
Nebraska Health System
Omaha,, Nebraska, United States, 68198-5130
United States, New York
Community Health Network, Inc
Rochester, New York, United States, 14642-0001
Beth Israel Medical Center
New York, New York, United States, 10003
University of Rochester Medical Center
Rochester, New York, United States, 14642-0001
Columbia University
New York, New York, United States, 10032-3784
NYU/Bellevue
New York, New York, United States, 10016-6481
McCree McCuller Wellness Center at the Connection
Rochester, New York, United States, 14642-0001
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401-1004
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0405
Cleveland Clinic
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109-1998
Case Western Reserve University
Cleveland, Ohio, United States, 44106-5083
United States, Rhode Island
Stanley Street Treatment and Resource
Providence, Rhode Island, United States, 02906
United States, Tennessee
Comprehensive Care Clinic
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75235-9173
United States, Washington
University of Washington (Seattle)
Seattle, Washington, United States, 98104
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Investigators
Study Chair: John G. Gerber, MD University of Colorado Health Science Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: ACTG A5186
Study First Received: January 26, 2004
Last Updated: September 15, 2008
ClinicalTrials.gov Identifier: NCT00076518     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
Antimetabolites
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Hyperlipidemias
Hypertriglyceridemia
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Infection
Procetofen
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009