HIV-associated neurocognitive disorders persist in the era of potent antiretroviral therapy
CHARTER Study
Abstract
Objectives:
This is a cross-sectional, observational study to determine the frequency and associated features of HIV-associated neurocognitive disorders (HAND) in a large, diverse sample of infected individuals in the era of combination antiretroviral therapy (CART).
Methods:
A total of 1,555 HIV-infected adults were recruited from 6 university clinics across the United States, with minimal exclusions. We used standardized neuromedical, psychiatric, and neuropsychological (NP) examinations, and recently published criteria for diagnosing HAND and classifying 3 levels of comorbidity (minimal to severe non-HIV risks for NP impairment).
Results:
Fifty-two percent of the total sample had NP impairment, with higher rates in groups with greater comorbidity burden (40%, 59%, and 83%). Prevalence estimates for specific HAND diagnoses (excluding severely confounded cases) were 33% for asymptomatic neurocognitive impairment, 12% for mild neurocognitive disorder, and only 2% for HIV-associated dementia (HAD). Among participants with minimal comorbidities (n = 843), history of low nadir CD4 was a strong predictor of impairment, and the lowest impairment rate on CART occurred in the subset with suppressed plasma viral loads and nadir CD4 ≥200 cells/mm3 (30% vs 47% in remaining subgroups).
Conclusions:
The most severe HAND diagnosis (HAD) was rare, but milder forms of impairment remained common, even among those receiving CART who had minimal comorbidities. Future studies should clarify whether early disease events (e.g., profound CD4 decline) may trigger chronic CNS changes, and whether early CART prevents or reverses these changes.
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Supplementary Material
COINVESTIGATORS
The CNS HIV Anti-Retroviral Therapy Effects Research (CHARTER) group is affiliated with Johns Hopkins University, Mount Sinai School of Medicine, University of California, San Diego, University of Texas, Galveston, University of Washington, Seattle, Washington University, St. Louis, and is headquartered at the University of California, San Diego, and includes the following: Director: Igor Grant, MD; Co-Directors: J. Allen McCutchan, MD, Ronald J. Ellis, MD, PhD, Thomas D. Marcotte, PhD; Center Manager: Donald Franklin, Jr.; Neuromedical Component: Ronald J. Ellis, MD, PhD (P.I.), J. Allen McCutchan, MD, Terry Alexander, RN; Laboratory, Pharmacology and Immunology Component: Scott Letendre, MD (P.I.), Edmund Capparelli, PharmD; Neurobehavioral Component: Robert K. Heaton, PhD (P.I.), J. Hampton Atkinson, MD, Steven Paul Woods, PsyD, Matthew Dawson; Virology Component: Joseph K. Wong, MD (P.I.); Imaging Component: Christine Fennema-Notestine, PhD (Co-P.I.), Michael J. Taylor, PhD (Co-P.I.), Rebecca Theilmann, PhD; Data Management Unit: Anthony C. Gamst, PhD (P.I.), Clint Cushman; Statistics Unit: Ian Abramson, PhD (P.I.), Florin Vaida, PhD; Protocol Coordinating Component: Thomas D. Marcotte, PhD (P.I.), Rodney von Jaeger, MPH; Johns Hopkins University Site: Justin McArthur (P.I.), Mary Smith; Mount Sinai School of Medicine Site: Susan Morgello, MD (Co-P.I.), and David Simpson, MD (Co-P.I.), Letty Mintz, NP; University of California, San Diego Site: J. Allen McCutchan, MD (P.I.), Will Toperoff, NP; University of Washington, Seattle Site: Ann Collier, MD (Co-P.I.), and Christina Marra, MD (Co-P.I.), Trudy Jones, MN, ARNP; University of Texas, Galveston Site: Benjamin Gelman, MD, PhD (P.I.), Eleanor Head, RN, BSN; and Washington University, St. Louis Site: David Clifford, MD (P.I.), Muhammad Al-Lozi, MD, Mengesha Teshome, MD.
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Information & Authors
Information
Published In
Copyright
Copyright © 2010 by AAN Enterprises, Inc.
Publication History
Received: January 5, 2010
Accepted: August 11, 2010
Published online: December 6, 2010
Published in issue: December 7, 2010
Disclosure
Dr. Heaton serves on a scientific advisory board for the NINCDS; serves on the editorial boards of the Journal of the International Neuropsychological Society, the Journal of Clinical and Experimental Neuropsychology, and The Clinical Neuropsychologist; has received royalties from the publication of Revised Comprehensive Norms for and Expanded Halstead-Reitan Battery: Demographically Adjusted Neuropsychological Norms for African American and Caucasian Adults (Psychological Assessment Resources, Inc., 1991-present), Revised Comprehensive Norms for and Expanded Halstead-Reitan Battery: Demographically Adjusted Neuropsychological Norms for African American and Caucasian Adults Scoring Program (Psychological Assessment Resources, Inc., 1994-present), and Wisconsin Card Sorting Test Manual-Revised and Expanded (Psychological Assessment Resources, Inc., 1991-present); and receives research support from the NIH (P30 MH62512 [coinvestigator], P50 DA26306 [coinvestigator], P01 DA12065 [coinvestigator], R01 MH60720 [coinvestigator], R01 MH73433 [PI], N01 MH22005 [coinvestigator], R01 MH58076 [coinvestigator], R01 MH78748 [coinvestigator], R01 MH78737 [coinvestigator], U01 MH83506 [coinvestigator], R01 MH83552 [coinvestigator], and R01 MH81861 [coinvestigator]). Dr. Clifford serves/has served on scientific advisory boards for Biogen Idec, Elan Corporation, Roche, Forest Laboratories, Inc., Genentech, Inc., GlaxoSmithKline, Millennium Pharmaceuticals, Inc., Schering-Plough Corp., Bristol-Meyers Squibb, and Genzyme Corporation; received speaker honoraria and funding for travel from GlaxoSmithKline, Millennium Pharmaceuticals, Inc., and Genentech Inc.; has received research support from Pfizer Inc, Schering-Plough Corp., Bavarian Nordic, NeurogesX, GlaxoSmithKline, Tibotec Therapeutics, Boehringer Ingelheim, and Gilead Sciences, Inc.; and receives research support from the NIH (UO1 NS32228 [PI], UO1 AI69495 [PI], NIMH 22005 CHARTER Project [Site PI], NIDA RO3 DA022137 [Co-I], NIMH MH058076 [Site PI], and R21 3857-53187 [PI]). Mr. Franklin receives research support from the NIH (NIMH N01 MH22005 [Center Manager]). Dr. Woods serves as Book Review Editor for the Journal of Clinical and Experimental Neuropsychology and on the editorial board of Archives of Clinical Neuropsychology; and receives research support from the NIH (P30 MH62512 [coinvestigator], P50 DA26306 [coinvestigator], N01 MH22005 [coinvestigator], R01 MH73419 [PI], P01 DA12065 [coinvestigator], and from Uniformed Services University/Henry M. Jackson Foundation. Dr. Ake has received research support from the NIH (NIHM N01 MH22005 [statistician] and NIHM P30 MH62512 [statistician]). Dr. Vaida served on a scientific advisory board for Ardea Biosciences, Inc.; serves as Research Methodology Section Editor for the Californian Journal of Health Promotion; and receives research support from Precision Photonics Corporation and the NIH (P30 MH62512 [coinvestigator], P50 DA26306 [coinvestigator], N01 MH22005 [coinvestigator], R01 MH083552 [coinvestigator], NIH R01 AI47033 [subcontract PI], U01 AI74521 [coinvestigator], R01 MH085608 [coinvestigator], and AI068543 [coinvestigator]. Dr. Ellis serves on the editorial advisory board for the Journal of Neuroimmune Pharmacology; has served on the speakers' bureau for and received speaker honoraria from GlaxoSmithKline; and has received research support from the NIH (R01 MH058076-12 [PI], P30 MH062512-09 [coinvestigator], DA012065-10 [coinvestigator], N01 MH22005-08 [coinvestigator], MH083506-02 [coinvestigator], MH083552-02 [coinvestigator], DA026306-01 [coinvestigator], MH085608-01 [coinvestigator], and DA026146 [coinvestigator]). Dr. Letendre serves on a scientific advisory board for Tibotec Therapeutics; has received speaker honoraria from GlaxoSmithKline, Tibotec Therapeutics, and Abbott; and receives research support from Abbott, Merck Serono, Tibotec Therapeutics, Schering-Plough Corp., GlaxoSmithKline, and the NIH (N01 MH22005 [coinvestigator], R01 MH58076 [coinvestigator], P01 DA12065 [coinvestigator], R01 NS36524 [coinvestigator], P30 MH62512 [coinvestigator], U01 MH083506 [consultant], R01 MH73433 [coinvestigator], U01 AI69432 [coinvestigator], R01 MH78748 [coinvestigator], and R21 MH85610 [PI]). Dr. Marcotte receives research support from the NIH (RO1 MH78748 [PI], P30 MH62512 [coinvestigator], P50 DA26306 [coinvestigator], N01 MH22005 [coinvestigator], RO1 MH38552 [coinvestigator], RO1 MH73433 [coinvestigator], R32 AA17321 [coinvestigator], R32 MH77487 [coinvestigator], and R01 MH64907 [coinvestigator]). Dr. Atkinson serves as a consultant for Eli Lilly and Company; and receives research support from the US Department of Veterans Affairs and the NIH (NIMH P30 MH62512 [coinvestigator], P50 DA26306 [coinvestigator], U01 MH83506 [coinvestigator], NIMH R01 MH73419 [coinvestigator], NIMH R01 MH58076 [coinvestigator], NIMH N01 MH22005 [coinvestigator], NIDA P01 DA12065 [coinvestigator], NIMH R01 MH79881 [coinvestigator], and NIMH R01 MH61146 [coinvestigator]). Dr. Rivera-Mindt receives research support from the NIH (N01 MH22005 [coinvestigator] and NIMH K23MH079718 [PI]. Mr. Vigil has received research support from the NIH (NIMH N01 MH22005 [Psychiatric Coordinator]). Dr. Taylor receives royalties from the publication of Revised Comprehensive Norms for an Expanded Halstead-Reitan Battery (Norms, Manual and Computer Program) (Psychological Assessment Resources, 2004); and receives research support from the US Veterans Administration and the NIH (NIMH P30 MH62512 [Consultant], NIMH N01 MH22005 [coinvestigator], NINDS R01 NS36524 [PI], and NIDA P01 DA12065 [coinvestigator]). Dr. Collier serves/has served on scientific advisory boards for Merck & Co., Inc.; Pfizer Inc, and GlaxoSmithKline; receives/has received research support from Merck & Co., Inc., Schering-Plough Corp, Boehringer Ingelheim, Gilead Sciences, Inc., Koronis Pharmaceuticals, Johnson & Johnson, and the NIH (NIAID AI 069434 [PI], NIAID AI27757 [PI on Core], NIHM N01 MH22005 [Site PI], NIAID AI069918 [coinvestigator of subcontract], NINDS RC1NS068904 [coinvestigator], NIAID P01 AI 057005 [PI on Core], and NIAID AI069438 [PI of Subcontract]); and she and an immediate family member own stock in Abbott and Bristol-Myers Squibb. Dr. Marra receives royalties from the publication of Infections of the Central Nervous System, 3d edition (Lippincott Williams & Wilkins, 2004) and from an article in UptoDate; and receives research support from the NIH (1R01 NS/AI 34235 [PI], N01 MH22005 [coinvestigator]). Dr. Gelman receives research support from the NIH/NIMH (U01MH083507 [PI], R01MH079886 [PI], and N01MH022005 [PI]). Dr. McArthur serves as a consultant to Allergan, Inc., Pfizer Inc, and Biogen Idec; receives royalties from the publication of Current Therapy in Neurologic Disease, 7th edition (Mosby, 2006); is an author on patents re: Device for thermal stimulation of small neural fibers and Immunophilin ligand treatment of antiretroviral toxic neuropathy; and receives research support from Biogen Idec, the NIH (R01 MH075673 [PI], RO1 NS44807 [PI], RO1 NS49465 [PI], and R01 MH067831 [Co-I]), the National Multiple Sclerosis Society, and the Foundation for Peripheral Neuropathy. Dr. Morgello has received research support from the NIH (U01MH083501 [PI] and N01MH22005 [PI]). Dr. Simpson has served on scientific advisory boards for Pfizer Inc, Cephalon, Inc., Eli Lilly and Company, GlaxoSmithKline, Allergan, Inc., Merz Pharmaceuticals LLC, MEDA Pharmaceuticals Ltd., Boehringer Ingelheim, Endo Pharmaceuticals, Biogen Idec, and Alpharma Inc.; serves on the editorial board of AIDS Patient Care; has served on speakers' bureaus for and received speaker honoraria from Eli Lilly and Company and GlaxoSmithKline; has served as a consultant for NeurogesX, Eli Lilly and Company, Regeneron Pharmaceuticals, Inc., GlaxoSmithKline, Allergan, Inc., Merz Pharmaceuticals LLC, and Torrey Pines; and receives research support from NeurogesX, Pfizer Inc, Allergan, Inc., Eli Lilly and Company, and the NIH (NINDS R01-NS-328-05 [coinvestigator], NINDS R24 MH59724 [coinvestigator], NIMH 00-AI-0005 [Co-PI], and NINDS R01-NS-41198 [coinvestigator]). Dr. McCutchan authors chapters on HIV for the Merck Manual; and receives research support from the NIH (P30 MH62512 [coinvestigator], U01 MH83506 [coinvestigator], CDC U2G PS00623 [PI], U01 AI69432 [coinvestigator], N01 MH22005 [coinvestigator], K30 RR22681 [coinvestigator], R01 MH58076 [coinvestigator], and U13 MH81676 [PI]). Dr. Abramson serves as an Associate Editor for the Journal of Nonparametric Statistics; and receives research support from the NIH (P30 MH62512 [coinvestigator], P50 DA26306 [coinvestigator], R01 MH61146 [coinvestigator], N01 MH22005 [coinvestigator], R01 DA21115 [coinvestigator], and R21 MH78728 [coinvestigator]). Dr. Gamst receives research support from Pfizer Inc, and the NIH (P30 MH62512 [coinvestigator], P50 DA26306 [coinvestigator], R01 HL95089 [coinvestigator], U01 MH83506 [coinvestigator], R01 HL84229 [coinvestigator], R01 MH79752 [coinvestigator], N01 MH22005 [coinvestigator], and U01 AG10483 [coinvestigator]), and from the National Science Foundation. Dr. Fennema-Notestine has received research support from the NIH (R21 NS069355 [PI], N01 MH22005 [coinvestigator], P30 MH062512 [coinvestigator], P50 DA026306 [coinvestigator], U24 RR21382 [coinvestigator], U24 RR021992 [coinvestigator], U24 RR019701 [coinvestigator], R01 MH079752 [coinvestigator], R01 AG031224 [coinvestigator], R01 AG022381 [coinvestigator], R01 MH084796 [coinvestigator], R01 AG024506 [coinvestigator]), the US Department of Veterans Affairs, and the Alzheimer's Association. Dr. Jernigan serves on the editorial advisory boards for Neuropsychology, Neurobiology of Aging: Brain Structure and Function, and Developmental Neuropsychology: Brain Imaging and Behavior; and receives research support from the NIH (NIMH P30 MH62512 [coinvestigator], P50 DA26306 [coinvestigator], NIMH R01 MH79752 [PI], NIMH N01 MH22005 [coinvestigator], NIDA P01 DA12065 [coinvestigator], R01 AA13419 [coinvestigator], R01 MH73419 [coinvestigator], NIDA RC2 DA29475 [PI]), and from the Lundbeck Foundation. Dr. Wong has served on a scientific advisory board for Abbott; serves on the editorial boards of the Journal of AIDS and AIDS Research and Therapy; has received research material support from Bristol-Myers Squibb; and has received research support from the NIH (R01 NS051132 [PI] and N01 MH22005 [Core PI], R21 MH083573 [PI], and R01 AI087145 [coinvestigator], and from the US Department of Veterans Affairs. Dr. Grant serves as an Associate Editor for the Journal of Neurovirology; and receives research support from the NIH (NIMH P30 MH62512 [PI], NIDA P50 DA26306 [PI], NIDA P01 DA12065 [PI], NIMH N01 MH22005 [PI], NIMH U01 MH83506 [PI], NIMH R01 MH78748 [coinvestigator], NIA R01 AG15301 [PI], NIMH R01 MH83552 [coinvestigator], and NIH/University of Nebraska P01 DA026146 [subcontract PI]).
Authors
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Statistical analysis was conducted by D.R. Franklin, Jr., Dr. Vaida, and Dr. Ake.
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