David B. Clifford, MD; Scott Evans, PhD; Yijun Yang, ScD; Edward P. Acosta, PharmD; Karl Goodkin, MD, PhD; Karen Tashima, MD; David Simpson, MD; David Dorfman, PhD; Heather Ribaudo, PhD; Roy M. Gulick, MD, MPH; A5097s Study Team*
Trial ACTG A5097s.
Acknowledgments: The authors thank the participants who volunteered to participate in this study.
Grant Support: By AI 38858 (AIDS Clinical Trials Group Central Grant), AI 01781, AI 25859, AI 25868, AI 25879, AI 25897, AI 25903, AI 25915, AI 25924, AI 27658, AI 27659, AI 27660, AI 27661, AI 27664, AI 27668, AI 27670, AI 27673, AI 27675, AI 27767, AI 28697, AI 32775, AI 32782, AI 34832, AI 38855, AI 39156, AI 42848, AI 42851, AI 46339, AI 46370, AI 46376, AI 46381, AI 46386, AI 50410, AI 51966, RR00044, RR00046, RR00047, RR00052, RR00096, RR00865, RR 02635, and subcontracts from grant AI 38858 with the Virology Support Laboratories at the University of Alabama, the University of Colorado Health Sciences Center, the University of North Carolina, and Vanderbilt University and the Pharmacology Support Laboratories at the University of Alabama from the National Institute of Allergy and Infectious Diseases, and by the Neurologic AIDS Research Consortium Grant NS 32228, National Institute of Neurological Disorders and Stroke, National Institutes of Health.
Potential Conflicts of Interest:Honoraria: D.B. Clifford (Bristol-Myers Squibb, Boehringer-Ingelheim); K. Tashima (Bristol-Myers Squibb, GlaxoSmithKline); R.M. Gulick (Bristol-Myers Squibb); Grants received: D.B. Clifford (Neurogesix, Saviant Pharmaceuticals); K. Tashima (Bristol-Myers Squibb, GlaxoSmithKline); R.M. Gulick (Boehringer-Ingelheim); Consultancies: R.M. Gulick (Boehringer-Ingelheim, GlaxoSmithKline).
Author Contributions: Conception and design: D.B. Clifford, E.P. Acosta, K. Tashima, D. Simpson, D. Dorfman, R.M. Gulick.
Analysis and interpretation of the data: D.B. Clifford, S. Evans, Y. Yang, E.P. Acosta, K. Goodkin, K. Tashima, D. Dorfman, H. Ribaudo, R.M. Gulick.
Drafting of the article: D.B. Clifford, S. Evans, Y. Yang, E.P. Acosta, D. Simpson, H. Ribaudo.
Critical revision of the article for important intellectual content: D.B. Clifford, S. Evans, Y. Yang, E.P. Acosta, K. Goodkin, K. Tashima, D. Simpson, H. Ribaudo, R.M. Gulick.
Final approval of the article: D.B. Clifford, S. Evans, Y. Yang, E.P. Acosta, K. Goodkin, K. Tashima, D. Simpson, H. Ribaudo, R.M. Gulick.
Provision of study materials or patients: D.B. Clifford, K. Tashima, R.M. Gulick.
Statistical expertise: D.B. Clifford, S. Evans, Y. Yang, H. Ribaudo.
Obtaining of funding: D.B. Clifford.
Administrative, technical, or logistic support: D.B. Clifford.
Collection and assembly of data: D.B. Clifford, K. Tashima, R.M. Gulick.
Requests for Single Reprints: David B. Clifford, MD, Washington University School of Medicine, Box 8111, Neurology Department, 660 South Euclid Avenue, St. Louis, MO 63110.
Current Author Addresses: Dr. Clifford: Washington University School of Medicine, Box 8111, Neurology Department, 660 South Euclid Avenue, St. Louis, MO 63110.
Dr. Evans: CBAR/Harvard School of Public Health, FXB-513, 651 Huntington Avenue, Boston, MA 02115.
Drs. Yang and Ribaudo: SDAC/Harvard School of Public Health, 651 Huntington Avenue, Boston, MA 02115.
Dr. Acosta: Department of Pharmacology and Toxicology, University of Alabama at Birmingham, 1530 Third Avenue South, VH 116, Birmingham, AL 35294.
Dr. Goodkin: Department of Psychiatry and Neurology, University of Miami School of Medicine, 1400 Northwest 10th Avenue, 803-A, Miami, FL 33136.
Dr. Tashima: The Miriam Hospital, M-974112, 164 Summit Avenue, Providence, RI 02906.
Drs. Simpson and Dorfman: Department of Clinical Neurophysiology, Mount Sinai School of Medicine, P.O. Box 1052, New York, NY 10029.
Dr. Gulick: The Cornell Clinical Trials Unit, Box 566, 525 East 68th Street, New York, NY 10021.
Clifford DB, Evans S, Yang Y, Acosta EP, Goodkin K, Tashima K, et al. Impact of Efavirenz on Neuropsychological Performance and Symptoms in HIV-Infected Individuals. Ann Intern Med. 2005;143:714-721. doi: 10.7326/0003-4819-143-10-200511150-00008
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Published: Ann Intern Med. 2005;143(10):714-721.
Neurologic toxicity is the most commonly reported adverse effect of the antiretroviral drug efavirenz.
In this substudy of a randomized, controlled trial, 12 of 200 (6%) HIV-infected individuals discontinued treatment with efavirenz because of central nervous system symptoms or mood disorders versus 0 of 103 individuals (0%) who were not receiving the drug. Although patients taking efavirenz had more neuropsychological symptoms, such as bad dreams, in the first week of therapy, no statistically significant neuropsychological differences were found at weeks 4, 12, and 24.
Some adverse neuropsychological effects associated with efavirenz are probably transient.
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