CNS HIV Anti-Retroviral Therapy Effects Research +,
University of California +,
San Diego +,
220 Dickinson Street +,
Suite B +,
CA 92103-8231 Telephone: (619) 543-5000 Fax: (619) 543-1235 E-mail: charter (at) ucsd.edu +,
Region: USA +
Clinical trial designed to determine how c … Clinical trial designed to determine how central and peripheral nervous system complications of HIV are affected by different histories and regimens of antiretroviral therapy (ART). Participants receive comprehensive neuromedical, neurocognitive, and laboratory examinations, with a subset undergoing host/viral genetic characterization and neuroimaging. In order to have a broad representation of participant characteristics, CHARTER is conducted at six performance sites nationally. CHARTER data and samples are available to qualified investigators. CHARTER is able to provide fluid specimens, pilot data, and analysis and interpretation expertise for qualified investigators.
The project is designed to assess a large number of HIV infected participants with a baseline visit only, and to follow approximately 600 of those individuals on a semi-annual basis. Approximately 180 individuals will continue to be followed through August 2015. All participants are HIV seropositive and complete a Core battery of neuromedical, laboratory, neuropsychological, and psychiatric assessments. A subset of those in the longitudinal cohort complete additional measures (e.g., CSF studies, structural MRI, proton spectroscopy, viral genetic analyses).
* Neuromedical Data: Medical History; Detailed ARV History; CDC Classification; ARV Adherence Estimates; Characteristics of Neurologic Disorders (e.g. Peripheral Neuropathy); Risk Group (sexual contact, IDU, transfusion, vertical); Anthropomorphic Measures
* Laboratory Data: Hematology Chemistry, Renal, and Hepatic Panels; Lipid Panels (select participants); Hepatitis Serologic Panels; Lactate (select participants); Lymphocyte Subsets HIV RNA; Plasma and CSF ARV Concentrations; Plasma Psychotropic Drug Concentrations; Biomarkers (cytokines, etc.); Host Genotyping
* Neurobehavioral Data: NP Characterization (raw, T scores, impairment classification); Substance Use History /Diagnoses; Psychiatric History/Diagnoses; Self-report Functioning Data; Mood Scales
* Neuroimaging Data (Select Participants): Structural MRI (white/gray matter abnormalities/volume loss); MR Spectroscopy (N-acetylaspartate, Choline, Myo-inositol levels); Diffusion Tensor Imaging (diffusion anisotropy)
* Virology Data (Select participants): Plasma genotypic ARV resistance, CSF genotypic ARV resistance
* Specimen Resources: CSF aliquots, Plasma aliquots, Serum aliquots, PAXGene DNA tubes, PAXGene RNA tubes
* Cohort Resources: Currently following 180 Participants; ~1600 Participants with Baseline visit; 674 Participants with at least 1 Follow-up visit; 141 Aging cohort (>55 years of age); 50 Acute and Early Infection Cohort (1st HIV+ test date within 1 year of first study visit) t date within 1 year of first study visit)
*Note: Neurolex imports many terms and their ids from existing community ontologies, e.g., the Gene Ontology. Neurolex, however, is a dynamic site and any content beyond the identifier should not be presumed to reflect the content or views of the source ontology. Users should consult with the authoritative source for each ontology for current information.