The Clinical Core provides an important and integral component of CFAR, bringing basic science and rational drug design and development with human volunteer studies. The Clinical Core has three facility components of importance; there are two clinical research environments (the UAB-AIDS Ambulatory Care Clinic and the UAB General Clinical Research Center) and the Clinical Laboratory Core (see description of facilities). In these environments, volunteers will be evaluated prospectively on pharmacokinetics, therapeutics and in vivo pathogenesis studies. Data management and retrieval as well as specimen storage will be standardized for CFAR investigators. Clinical studies will be performed with Institutional Review Board approval.
The Specific Aims for this Clinical Core are: 1. To provide a mechanism for CFAR investigators to obtain specimens (tissue, cells, body fluids, etc.) from consenting volunteers who are evaluated serially and prospectively for basic research studies. 2. To maintain resources of determining drug pharmacokinetics, including metabolism, disposition, clearance and modeling. 3. To make available all identification facilities for evaluation of a consenting patient by CFAR investigators. 4. To develop the Clinical setting for performance of drug evaluations of locally developed therapeutics as well as national therapeutic priorities including Phase I pharmacokinetics and Phase II, III controlled trials for consenting volunteers. 5. To provide contemporary biostatistical resources for data management, data retrieval, pharmacokinetic modeling and study design. 6. To develop novel approaches for allowing translation of developments in the drug targeting core and vaccine development.
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