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

NCT00076518 | Completed Phase 2

• 3 other identifiers: A518610686ACTG A5186
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

HIV Infections; Hypertriglyceridemia

Keywords

Treatment Experienced

Interventions

Fenofibrate DRUG

Fish Oil DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, 30308, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267-0405, United States

Location

Case CRS

Cleveland, Ohio, 44106-5083, United States

Location

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, 02906, United States

Location

Related Publications (6)

• 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.

  PMID: 10708054 BACKGROUND

• 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.

  PMID: 12203183 BACKGROUND

• 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.

  PMID: 3990714 BACKGROUND

• Harris WS. Nonpharmacologic treatment of hypertriglyceridemia: focus on fish oils. Clin Cardiol. 1999 Jun;22(6 Suppl):II40-3. doi: 10.1002/clc.4960221408.

  PMID: 10376196 BACKGROUND

• 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.

  PMID: 9456255 BACKGROUND

• 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.

  PMID: 17971707 DERIVED

MeSH Terms

Conditions

HIV Infections; Hypertriglyceridemia

Interventions

Fenofibrate; Fish Oils

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

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Oils; Lipids

Study Officials

• John G. Gerber, MD

  University of Colorado Health Science Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2004
• First Posted: February 4, 2004
• Study Completion: September 1, 2005
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (5)