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Clinical Core

Clinical Outcomes CorePhoto: Clinical Outcomes Core Members

Core Mission

The Clinical Outcomes Core will serve the following functions:

  • Provide the resources necessary to validate new, robust, and biologically valid outcome measures for epidemiological research and treatment trials in HIV-associated cognitive disorders.
  • Develop new instruments that will integrate measurements of medication adherence and cognition.
  • Provide validated test batteries critical for rapid development of clinical trials of novel therapeutic agents for the treatment of HIV dementia.
  • Develop a logical data infrastructure across multi-center modalities to allow efficient querying of clinical and laboratory data
  • Develop and apply appropriate statistical and epidemiological methods to support studies involving the Center Grant resources.
  • Provide a resource for and linkage with ongoing Neuro-AIDS trial consortia including the Neurological AIDS Research Consortium (NARC, PI-Dr David Clifford), and the AIDS Clinical Trials Group.

Core Overview

The Clinical Outcomes Core plays a central role in the proposed center, and will interact with several of the Cores.

NedNed Sacktor, MD - Core Director
President of World Neurology Foundation

 The Core is justified by the recognized need to develop new outcome measures for HIV-associated cognitive disorders in the era of highly active antiretroviral therapy (HAART) that are not only robust and well validated, but also sensitive to changes that are expected earlier in the development of HIV-associated cognitive impairment. Also, the statistical power of recent trials for HIV dementia has been limited by excessive variance in the scores of standard neuropsychological test batteries.

There is currently no funding venue for the kind of outcome measure development proposed in this Core.

Dr. Ned Sacktor will direct this Core and oversee the collection of clinical data including neurological assessments. Dr. Cynthia Munro will oversee the collection of neuropsychological data and assist Dr. Sacktor in subject characterization. Dr. Richard Skolasky will collaborate with them on the design, data collection and management, statistical analyses, and interpretation of the performance characteristics of the instruments. 

Clinical Trial News

Antidepressant Paroxetine Can Reverse Cognitive Impairment in HIV Patients- Study 
Health Newsline, February 26, 2016 | by: Neelam
“Over a period of 20 years and after 10 clinical trials, this is the first time we have been able to clearly demonstrate benefit in a summary measure of cognitive performance for patients with HIV-associated neurocognitive disorders,” said lead study author Ned Sacktor, Professor of Neurology at the Johns Hopkins University School of Medicine in the US.

Recent Publications

  • Sacktor N, Skolasky RL, Moxley R, Wang S, Mielke MM, Munro C, Steiner J, Nath A, Haughey N, McArthur J (2018). Paroxetine and fluconazole therapy for HIV-associated neurocognitive impairment: results from a double-blind, placebo-controlled trial. J Neurovirol. 16-27. doi: 10.1007/s13365-017-0587-z. Epub 2017 Oct 23. PMID: 29063516
  • Joska, J. A., Witten, J., Thomas, K. G., Robertson, C., Casson-Crook, M., Roosa, H., ... Sacktor, N. C. (2016). A Comparison of Five Brief Screening Tools for HIV-Associated Neurocognitive Disorders in the USA and South AfricaAIDS and Behavior, 1-11. 

  • Saylor, D., & Sacktor, N. (2016). Cognitive Impairment Among Older Individuals with HIV InfectionCurrent Geriatrics Reports,5(2), 63-70. 

  • Saylor, D., Dickens, A. M., Sacktor, N., Haughey, N., Slusher, B., Pletnikov, M., ... McArthur, J. C. (2016). HIV-associated neurocognitive disorder - Pathogenesis and prospects for treatmentNature Reviews Neurology12(4), 234-248.

  • Soldan, A., Pettigrew, C., Cai, Q., Wang, M. C., Moghekar, A. R., O'Brien, R. J., ... Fisher, K. (2016). Hypothetical preclinical Alzheimer disease groups and longitudinal cognitive changeJAMA Neurology73(6), 698-705.

  • Fazeli, P. L., Moore, D. J., Franklin, D. R., Umlauf, A., Heaton, R. K., Collier, A. C., ... Teshome, M. (2016). Lower CSF Aβ is associated with HAND in HIV-infected adults with a family History of DementiaCurrent HIV Research14(4), 324-330.

  • Sacktor, N., Skolasky, R. L., Seaberg, E., Munro, C., Becker, J. T., Martin, E., ... Miller, E. (2016). Prevalence of HIV-associated neurocognitive disorders in the Multicenter AIDS Cohort StudyNeurology86(4), 334-340.

Highlighted Publication

Impairments of Motor Function While Multitasking in HIV. Sharif I. Kronemer, Jordan A. Mandel, Ned C. Sacktor and Cherie L. Marvel | Frontiers in Human Neuroscience, published April 28, 2017

Abstract: Human immunodeficiency virus (HIV) became a treatable illness with the introduction of combination antiretroviral therapy (CART). As a result, patients with regular access to CART are expected to live decades with HIV. Long-term HIV infection presents unique challenges, including neurocognitive impairments defined by three major stages of HIV-associated neurocognitive disorders (HAND). The current investigation aimed to study cognitive and motor impairments in HIV using a novel multitasking paradigm. Unlike current standard measures of cognitive and motor performance in HIV, multitasking increases real-world validity by mimicking the dual motor and cognitive demands that are part of daily professional and personal settings (e.g., driving, typing and writing). Moreover, multitask assessments can unmask compensatory mechanisms, normally used under single task conditions, to maintain performance. This investigation revealed that HIV+ participants were impaired on the motor component of the multitask, while cognitive performance was spared. A patient-specific positive interaction between motor performance and working memory recall was driven by poor HIV+ multitaskers. Surprisingly, HAND stage did not correspond with multitask performance and a variety of commonly used assessments indicated normal motor function among HIV+ participants with poor motor performance during the experimental task. These results support the use of multitasks to reveal otherwise hidden impairment in chronic HIV by expanding the sensitivity of clinical assessments used to determine HAND stage. Future studies should examine the capability of multitasks to predict performance in personal, professional and health-related behaviors and prognosis of patients living with chronic HIV.

Core Members

Ned Sacktor, MD (Director, Clinical Outcomes Core)
Deanna Saylor, MD, MHS (Co-Investigator)
Cynthia Munro, MA, PhD (Neuropsychologist)
Richard Skolasky, MA, ScD (Co-Investigator)
Lai, Sheghan, MD, MPH (Statistician)
Richard Moxley (Research Coordinator)
Corey Demsky (Research Coordinator)
Vincent Rogalski (Research Coordinator)
Jason Creighton (Neuropsychological Test Administrator)
Liping Guo (Research Specialist)


Adriana Bora, PhD
Kenneth Witwer, PhD
Andrew Mammen, MD, PhD
Cherie Marvel, PhD
Kamil Khalili, PhD (Temple University)
Avindra Nath, MD (National Institutes of Heath)

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