Core C: Clinical ABSTRACT The Penn CFAR Clinical Core (Core C) forms the central nexus for patient-oriented interdisciplinary research conducted by CFAR investigators to advance knowledge that will improve the lives of people affected by HIV/AIDS, including adults, adolescents (behaviorally infected), and children (perinatally infected). Core C's overarching objectives are to: (a) galvanize basic, translational, clinical, epidemiologic, and behavioral research by providing investigators with a broad range of data and clinical material from HIV-infected individuals, including both biomedical and behavioral data, and stored and freshly-acquired specimens including a highly innovative new program of access to lymphoid and other tissues; (b) support for recruitment of HIV-infected or at-risk individuals into clinical studies; (c) provide advice, consultation and expertise in utilization of these services and clinical study development; and (d) provide education, training, mentorship and leadership in clinical research. Core C is led by Drs. Ian Frank (Director), and Elizabeth Lowenthal and Vincent Lo Re (Co-Directors). Over the current funding period, Core C has contributed to >150 research projects with important discoveries in HIV reservoirs, first-in-human clinical trials, and other HIV/AIDS research priority areas. The Clinical Core achieves its mission through essential services for CFAR investigators including: (1) Data and subject recruitment via an Adult/Adolescent Database comprised of >3000 patients cared for at one adolescent and 4 adult HIV practices, and a Pediatric Database with longitudinal data on 275 perinatally infected children; (2) Patient material via the CFAR Adult/Adolescent & Pediatric Specimen Repositories linked to the Databases, and by procurement of fresh material, including blood, apheresis products, genital secretions, gastrointestinal tissue, lymph node biopsies & aspirates, and lymph via cannulation of the thoracic duct; (3) Consultation on design and execution of clinical and translational studies, assistance with IRB issues, and laboratory assistance with processing, storage, and shipment of clinical specimens; (4) Educational activities & mentorship for trainees and junior faculty to advance their research and enhance success in clinical/translational AIDS research. The Clinical Core's services, leadership and expertise have evolved over the current funding cycle in response to emerging opportunities and priorities identified through proactive strategic planning, user feedback, and input from internal and external advisors. The Core fosters research aligned with NIH and Penn CFAR HIV/AIDS research priorities, including the agendas of the two CFAR Scientific Working Groups: HIV Reservoirs & Tissue Immunology and Technology to Reduce HIV Disparities. Looking ahead, several recently-introduced innovations will be featured and expanded in the coming funding cycle, including access to lymphoid tissues relevant to understanding virus persistence, immunologic control and the HIV cure research agenda; increased emphasis on adolescent populations, and access to additional data resources relevant to research on HIV disparities and increased integration with Philadelphia Department of Health activities.
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