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Fish Oil and Fenofibrate for the Treatment of Hypertriglyceridemia in HIV-Infected Subjects on Antiretroviral Therapy: Results of ACTG A5186

Gerber, John G MD*; Kitch, Douglas W MS; Fichtenbaum, Carl J MD; Zackin, Robert A ScD; Charles, Stéphannie BA§; Hogg, Evelyn BA; Acosta, Edward P PharmD; Connick, Elizabeth MD*; Wohl, David MD#; Kojic, E Milu MD**; Benson, Constance A MD††; Aberg, Judith A MD‡‡for the AIDS Clinical Trial Group A5186 Team

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 1st, 2008 - Volume 47 - Issue 4 - p 459-466
doi: 10.1097/QAI.0b013e31815bace2
Clinical Science

Introduction: Fish oil has been shown to reduce serum triglyceride (TG) concentrations. In HIV-infected patients on antiretroviral therapy, high TG concentrations likely contribute to increased risk of cardiovascular disease. AIDS Clinical Trials Group A5186 examined the safety and efficacy of fish oil plus fenofibrate in subjects not achieving serum TG levels ≤200 mg/dL with either agent alone.

Methods: One hundred subjects on highly active antiretroviral therapy with serum TG concentrations ≥400 mg/dL and low-density lipoprotein cholesterol ≤160 mg/dL were randomized to 3 g of fish oil twice daily or 160 mg of fenofibrate daily for 8 weeks. Subjects with a fasting TG level >200 mg/dL at week 8 received a combination of fish oil and fenofibrate in the same doses from week 10 to week 18.

Results: Median baseline TG was 662 mg/dL in the fish oil group and 694 mg/dL in the fenofibrate group (P = not significant). Fish oil reduced TG levels by a median of 283 mg/dL (46%), fenofibrate reduced them by 367 mg/dL (58%), and combination therapy reduced them by 65.5%. Combination therapy achieved TG levels of ≤200 mg/dL in 22.7% subjects. Fish oil had no measurable effect on immunologic parameters or the pharmacokinetics of lopinavir.

Conclusions: Fish oil was safe when administered alone or combined with fenofibrate and significantly reduced TG levels in HIV-infected subjects with hypertriglyceridemia.

From the *Department of Medicine, University of Colorado Health Sciences Center, Denver, CO; †Complications of HIV, Adult Division, Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA; ‡Department of Medicine, University of Cincinnati Medical Center, Cincinnati, OH; §Frontier Science and Technical Research Foundation, Amherst, NY; ∥Social and Scientific Systems, Silver Spring, MD; ¶Department of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, AL; #Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC; **Department of Medicine, Brown Medical School, Providence, RI; ††Department of Medicine, University of California, San Diego, San Diego, CA; and ‡‡Department of Medicine, New York University, New York, NY.

Received for publication April 11, 2007; accepted September 19, 2007.

R. A. Zackin, ScD, is deceased.

Subject visits and laboratory assays were supported by the AIDS Clinical Trials Group (ACTG), funded by the National Institute of Allergy and Infectious Diseases (NIAID) and National Center for Complementary and Alternative Medicine. Supported by NIAID grants AI-38858 and AI-068636 to the ACTG; grants AI-32770, AI-69450, and RR00051 to the University of Colorado Health Sciences Center (J. G. Gerber, E. Connick); grants AI-38855 and AI-068636 to the Statistical and Data Analysis Center/Harvard School of Public Health (D. W. Kitch, R. A. Zackin); grants AI-25897 and AI-069513 to the University of Cincinnati (C. J. Fichtenbaum); grants M01RR-0032, 3U01AI32775-13S3, and AI-069452 to the University of Alabama (E. P. Acosta); grants AI-50410, AI-25868, AI-69423, and RR00046 to the University of North Carolina (D. Wohl); grant AI-46381 to The Miriam Hospital, Brown Medical School (E. M. Kojic); grants AI-27670 and AI-069432 to the University of California, San Diego Antiviral Research Center (C. A. Benson); and grants AI -27665, AI-069532, and M01RR00096 to the New York University (J. A. Aberg).

Fenofibrate was donated by Abbott Laboratories (Abbott Park, IL), and fish oil was purchased from Advanced Nutritional Technologies, Inc. (Dublin, CA).

Data presented in part at the 13th Conference on Retroviruses and Opportunistic Infections, Denver, CO, February 5-8, 2006 (abstract 146).

Clinical Trials.gov Identifier: NCT00076518

C. J. Fichtenbaum, C. A. Benson, and J. A. Aberg have served on the Advisory Board for Abbott Labs and have received honoraria and research grant support.

Correspondence to: Judith Aberg, MD, New York University, Bellevue C and D Building, Room 558, 550 First Avenue, New York, NY 10016-6481 (e-mail: judith.aberg@med.nyu.edu).

© 2008 Lippincott Williams & Wilkins, Inc.