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The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)

Primary Purpose

HIV Infections, Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate
Fish Oil
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ucsf Aids Crs
  • The Ponce de Leon Ctr. CRS
  • Univ. of Cincinnati CRS
  • Case CRS
  • The Miriam Hosp. ACTG CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 26, 2004
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00076518
Brief Title
The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hypertriglyceridemia
Keywords
Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Type
Drug
Intervention Name(s)
Fish Oil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John G. Gerber, MD
Organizational Affiliation
University of Colorado Health Science Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
The Ponce de Leon Ctr. CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0405
Country
United States
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5083
Country
United States
Facility Name
The Miriam Hosp. ACTG CRS
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10708054
Citation
Mulligan K, Grunfeld C, Tai VW, Algren H, Pang M, Chernoff DN, Lo JC, Schambelan M. Hyperlipidemia and insulin resistance are induced by protease inhibitors independent of changes in body composition in patients with HIV infection. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):35-43. doi: 10.1097/00126334-200001010-00005.
Results Reference
background
PubMed Identifier
12203183
Citation
Bonnet F, Bonarek M, De Witte S, Beylot J, Morlat P. Efavirenz-associated severe hyperlipidemia. Clin Infect Dis. 2002 Sep 15;35(6):776-7. doi: 10.1086/342326. No abstract available.
Results Reference
background
PubMed Identifier
3990714
Citation
Phillipson BE, Rothrock DW, Connor WE, Harris WS, Illingworth DR. Reduction of plasma lipids, lipoproteins, and apoproteins by dietary fish oils in patients with hypertriglyceridemia. N Engl J Med. 1985 May 9;312(19):1210-6. doi: 10.1056/NEJM198505093121902.
Results Reference
background
PubMed Identifier
10376196
Citation
Harris WS. Nonpharmacologic treatment of hypertriglyceridemia: focus on fish oils. Clin Cardiol. 1999 Jun;22(6 Suppl):II40-3. doi: 10.1002/clc.4960221408.
Results Reference
background
PubMed Identifier
9456255
Citation
Pichard C, Sudre P, Karsegard V, Yerly S, Slosman DO, Delley V, Perrin L, Hirschel B. A randomized double-blind controlled study of 6 months of oral nutritional supplementation with arginine and omega-3 fatty acids in HIV-infected patients. Swiss HIV Cohort Study. AIDS. 1998 Jan 1;12(1):53-63. doi: 10.1097/00002030-199801000-00007.
Results Reference
background
PubMed Identifier
17971707
Citation
Gerber JG, Kitch DW, Fichtenbaum CJ, Zackin RA, Charles S, Hogg E, Acosta EP, Connick E, Wohl D, Kojic EM, Benson CA, Aberg JA. Fish oil and fenofibrate for the treatment of hypertriglyceridemia in HIV-infected subjects on antiretroviral therapy: results of ACTG A5186. J Acquir Immune Defic Syndr. 2008 Apr 1;47(4):459-66. doi: 10.1097/QAI.0b013e31815bace2. Erratum In: J Acquir Immune Defic Syndr. 2009 Mar 1;50(3):343.
Results Reference
derived

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The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)

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