New York University HIV/AIDS Clinical Trial Unit

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DESCRIPTION (provided by applicant): The NYU/Bellevue CTU's proposal is to support three Clinical Research Sites, two domestic sites affiliating with the ACTG and HVTN and one international site in Mombasa, Kenya. The three individual sites currently work in close collaboration largely through the efforts of our NIAID sponsored Center for AIDS Research (CFAR),directed by Dr. Fred Valentine. It should be noted that our CFAR was just refunded in 2005 for an additional 5 year period. Specimen management and laboratory measurements are cjrrently provided by the same CFAR laboratories for both the ACTU and Vaccine studies. All three sites have demonstrated their ability to recruit, accrue and retain subjects in studies addressing the high priority scientific research detailed in the RFA. All three sites meet the CRS- required capabilities to: recruit, screen, and enroll participants; perform protocol required assessments; manage study products; dispense investigational agents; monitor for, assess arid report adverse events; collect, process, store and ship specimens; collect, manage and submit clinical research data, that meets all data reporting requirements of the Network(s) and DAIDS conduct internal quality assurance create, maintain and store research records including participant files, source documents, regulatory files, subject identification information, clinical reports, and case report forms. As PI of the CTU, Dr. Aberg accepts the primary responsibilities outlined in the application and additionally as she is Director of HIV for Bellevue Hospital Center, she assures that any subjects who become HIV positive while participating in an HIV vaccine trial will be appropriately and immediately offered primary care either at Bellevue or a clinic of that subject's preference as well as information on available clinical trials evaluating primary infection. The ACTG and HVTN have contributed immensely to the clinical care of persons living with HIV as reflected by the numerous references to ACTG studies in all the national guidelines. Our unit has given significant scientific contributions to the concept and design of many studies and will continue to do so. ADMINISTRATIVE COMPONENT: