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Clinical Outcomes Core

photo of clinical core faculty
Dr. Ned Sacktor (center) and Core Team Members

Clinical Outcomes Core Mission:

The Core will provide the support necessary for a cohort to evaluate new surrogate markers and outcome measures of CNS function. The Core will provide well-characterized individuals for developmental projects such as novel neuroimaging outcomes and laboratory measures which may be more sensitive to CNS dysfunction and response to treatment than neuropsychological test measures.

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.

Goals and Objectives of the Clinical Outcomes Core:

  • To continue a clinical cohort of well-characterized HIV+ and demographically-matched HIV- individuals to evaluate new outcome measures to improve the efficiency of clinical trials for HIV-associated neurocognitive disorders (HAND).
  • To liaise with other NIMH Centers, other funded IPCPs involved in NeuroAIDS therapeutics, and the Johns Hopkins University (JHU) Brain Science Institute’s neurotranslational unit to help identify and develop potential candidate agents for inclusion in clinical trials.
  • To provide the resources necessary to conduct small early phase studies to evaluate potential novel compounds to treat HAND.
  • To maintain a data infrastructure to allow for efficient querying of clinical and laboratory data.
  • To provide statistical support for studies involving the Center Grant resources.
  • Provide a resource for and linkage with ongoing Neuro-AIDS trial consortia including the Neurological AIDS Research Consortium and the AIDS Clinical Trials Group (ACTG).

Team Members

Ned Sacktor, M.D. (Director, Clinical Outcomes Core)
Cynthia Munro, Ph.D. (Neuropsychologist)
Richard Skolasky, M.A., Sc.D. (Statistitian)
Richard Moxley (Research Coordinator)
Heidi Roosa (Research Coordinator)
Vincent Rogalski (Research Coordinator)
Jason Creighton (Neuropsychological Test Administrator)
Liping Guo (Research Assistant)

Collaborators

Adriana Bora, Ph.D.
Kenneth Witwer, Ph.D.
Andrew Mammen, M.D., Ph.D.
Cherie Marvel, Ph.D.
Kamel Khalili, Ph.D. (Temple University)
Avindra Nath, M.D. (Neuroscience at National Institutes of Health)

 
 
 
 
 
 

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