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Absence of Sustained Hyperlactatemia in HIV-Infected Patients With Risk Factors for Mitochondrial Toxicity

Wohl, David A. MD*; Pilcher, Christopher D. MD*; Evans, Scott PhD; Revuelta, Manuel MD; McComsey, Grace MD§; Yang, Yijun ScD; Zackin, Robert PhD; Alston, Beverly MD; Welch, Stacey MA; Basar, Michael BA#; Kashuba, Angela PharmD**; Kondo, Pualani††; Martinez, Ana RPh‡‡; Giardini, Jeffrey BS§§; Quinn, Joseph RN∥∥; Littles, Melvin AA¶¶; Wingfield, Harry MFA##; Koletar, Susan L. MD***Adult AIDS Clinical Trials Group A5129 Team

JAIDS Journal of Acquired Immune Deficiency Syndromes: March 1st, 2004 - Volume 35 - Issue 3 - p 274-278
Brief Report: Clinical Science

Background The prevalence of asymptomatic hyperlactatemia among HIV-infected individuals has been reported to be 4% to 36%. This variability may reflect differences in the definition of and risk factors for hyperlactatemia and/or techniques for venous lactate collection.

Methods We examined the prevalence of elevated venous lactate collected in accordance with Adult AIDS Clinical Trials Group (AACTG) guidelines among HIV-infected and nucleoside analogue–treated subjects with risk factors associated with hyperlactatemia. Sustained hyperlactatemia was defined as 2 consecutive levels ≥1.5 but ≤4 times the upper limit of normal (ULN) within 30 days.

Results Eighty-three subjects were enrolled. Two thirds had ≥2 risk factors, with 11% having >4 risk factors. The median entry venous lactate level was 1.2 mmol/L (range: 0.7–5.1 mmol/L). Two subjects had a lactate level >1.5 times the ULN: 1 with a value of 2.1 times the ULN at entry and a week 2 level of 1.2 times the ULN and a second subject with a week 2 value of 1.9 times the ULN but an entry level of 1.4 times the ULN. The latter subject developed symptomatic lactic acidosis 3 weeks following study discontinuation.

Conclusions Sustained asymptomatic hyperlactatemia among subjects with risk factors associated with hyperlactatemia was not observed when venous lactate was measured in a standardized fashion. One case of hyperlactatemia that evolved into symptomatic lactic acidosis was diagnosed soon after the completion of the study, however. Our findings indicate that asymptomatic hyperlactatemia is either very rare or an artifact of collection technique.

From the *Department of Medicine, University of North Carolina, Chapel Hill, NC; †Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA; ‡Department of Medicine, Beth Israel Medical Center, New York, NY; §Departments of Medicine and Pediatrics, Case Western Reserve University, Cleveland, OH; †Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA; †Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA; Division of AIDS, National Institutes of Health, Bethesda, MD; ¶Social and Scientific Systems, Silver Spring, MD; #Complications Section, Frontier Science and Technology Research Foundation, Amherst, NY; **University of North Carolina School of Pharmacy, Division of Pharmacotherapy, University of North Carolina, Chapel Hill, NC; ††Retrovirology Research Laboratory, University of Hawaii, Honolulu, HI; ‡‡Pharmacology Affairs Branch, Division of AIDS, National Institutes of Health, Bethesda, MD; §§Frontier Science and Technology Research Foundation, Amherst, NY; ∥∥AIDS Clinical Trials Unit, University of Pennsylvania, Philadelphia, PA; ¶¶AIDS Clinical Trials Unit, Mount Sinai School of Medicine, New York, NY; ##AIDS Clinical Trials Unit, University of Alabama, Birmingham, AL; ***Department of Medicine, Ohio State University, Columbus, OH.

Received for publication September 23, 2003; accepted December 10, 2003.

Supported by the National Institute of Allergy and Infectious Diseases, AIDS Clinical Trials Group (grants AI-25868-15, AI-25924, AI-25879, and AI-46370); General Clinical Research Center Program of the Division of Research Resources, National Institutes of Health (grants RR00046 and RR00080); and University of North Carolina Center for AIDS Research Program of the National Institutes of Health (grant 9P30 AI50410).

Reprints: David A. Wohl, 211A West Cameron Avenue, Chapel Hill, NC 27599 (e-mail:wohl@med.unc.edu).

© 2004 Lippincott Williams & Wilkins, Inc.