This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. CHARTER is a collaborative venture with six sites around the country. Over four years, the Johns Hopkins CHARTER site will recruit approximately 536 HIV-infected subjects at varying stages of disease and with differing histories of anti-retroviral treatment for a Screening Stage 1 visit. The areas addressed in Screening are demographic characteristics, brief neuromedical history, brief neuropsychological assessment, psychiatric and substance use screening, and brief history of treatment. These data will assess the representativeness of our sample and determine whether the subject fits into a priority area within CHARTER. Of those who enter CHARTER for a Screening visit, 268 of those qualified for inclusion will be asked to participate in the full CHARTER protocol for a Cross-Sectional Stage 2 evaluation. The Cross-Sectional evaluation will take five to seven hours, which may be divided over several days, provided it is complete within 30 days of the Screening visit. This evaluation yields higher order summary information, such as degree of neurocognitive impairment and ability areas that are impaired, specific neurological diagnoses (e.g., presence of peripheral neuropathy), and presence or absence of substance use diagnosis. In addition, 100 participants (25 individuals identified annually over four years) taken from the cross-sectional cohort will enter a Longitudinal Pathogenesis Stage 3 study. These semi-annual evaluations will begin six months after the Cross-Sectional visit and continue until the end of the study. There is the option (at NIH discretion) that the project may continue for seven years total, allowing for continued follow-up of 50 Longitudinal participants. Longitudinal participants will be selected on the basis of identified groups of interest defined as groups of subjects with characteristics whose long-term follow-up would shed additional light on important questions in regard to neuroAIDS in the era of HAART. These groups of interest include persons with neurocognitive impairment who do or do not have high viral loads in the CSF, ARV naive individuals, and persons with advanced disease who have either failed or are unable to continue combination therapies (Group A). Additional groups of interest include those with peripheral neuropathies (Group B), those with lipoatrophy (Group C), and persons who develop MRI-detected brain white matter disease despite apparently adequate ARV treatment (Group D). Each Longitudinal visit will include the same core diagnostic evaluation as the Cross-Sectional visit with additional testing depending on group. Group A will have MRI and MRS scans performed. Group B will undergo Qualitative Sensory Testing (QST) and Nerve Conduction Velocity (NCV) and complete the Gracely Pain Scale. Group C will have fasting lipids taken, as well as Body Mass Index and anthropomorphic measurements. Group D will have no additional tests.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000052-45
Application #
7378848
Study Section
Special Emphasis Panel (ZRR1-CR-1 (01))
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
45
Fiscal Year
2006
Total Cost
$142,902
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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