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Impact of Efavirenz on Neuropsychological Performance and Symptoms in HIV-Infected Individuals

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*
[+] Article and Author Information

From Washington University School of Medicine, St. Louis, Missouri; Harvard School of Public Health, Boston, Massachusetts; University of Alabama, Birmingham, Alabama; University of Miami School of Medicine, Miami, Florida; Miriam Hospital, Providence, Rhode Island; and Mount Sinai School of Medicine and Weill Medical College of Cornell University, New York, New York.


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.


Ann Intern Med. 2005;143(10):714-721. doi:10.7326/0003-4819-143-10-200511150-00008
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This investigator-initiated trial was a substudy of the AIDS Clinical Trials Group study A5095, a randomized, double-blind trial of 3 antiretroviral regimens: zidovudine and lamivudine in combination with efavirenz; abacavir; or abacavir and efavirenz in combination (4). For simplicity, we will refer to 2 groups: patients who received efavirenz (with or without abacavir) and those who did not. Randomization was performed centrally without reference to center. The study was supported by the National Institutes of Health (NIH) and was approved by the institutional review boards at each of the participating institutions, with each patient providing informed consent to participate in the substudy. All patients at sites taking part in the substudy were invited to participate before randomization for the parent study (Figure 1). Unblinding and within-class substitutions were allowed in cases of treatment-limiting toxicity (we substituted stavudine for zidovudine, didanosine for abacavir, and nevirapine for efavirenz). Participants had not previously received antiretroviral therapy, and their baseline plasma HIV-1 RNA levels were greater than 400 copies/mL. Parent study A5095 enrolled 1147 participants, of whom 303 at 36 clinical trials units volunteered to participate in the additional evaluations for A5097s. Participants were recruited between March 2001 and January 2002.

Topics

efavirenz ; hiv

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Figures

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Figure 1.
CONSORT diagram of substudy 5097s.

CONSORT = Consolidated Standards of Reporting Trials; EFV = efavirenz.

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Figure 2.
Median changes from baseline over time and 95% CIs for each time point.

Below each plot are the numbers of patients available to compute these measures.A. Change in neuropsychological performance over the duration of the study. B. Changes in depression from the Center for Epidemiologic Studies Depression Scale. C. Anxiety performance changes. D. Presumptive efavirenz (EFV)-related symptom score changes. E. Systemic symptom score changes. F. Change in sleep variables as measured by the Pittsburgh Sleep Quality Index. EFV = efavirenz.

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Summary for Patients

Neuropsychological Side Effects of Efavirenz

The summary below is from the full report titled “Impact of Efavirenz on Neuropsychological Performance and Symptoms in HIV-Infected Individuals.” It is in the 15 November 2005 issue of Annals of Internal Medicine (volume 143, pages 714-721). The authors are D. Clifford, S. Evans, Y. Yang, E.P. Acosta, K. Goodkin, K. Tashima, D. Simpson, D. Dorfman, H. Ribaudo, and R.M. Gulick for the A5097s Study Team.

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