The NJ Pediatric AIDS Consortium (NJ-PAC) is recompeting for RFA AI-96- 001 to maintain its NIAID pediatric and perinatal-sponsored Clinical Trials Program. This program, funded since 1987, consists of an administrative unit, primary perinatal component, and Center for Laboratory Investigations (CLI) in the DAIID, Department of Pediatrics at the NJMS and 4 subunit clinical trial sites (Children Hospital of New Jersey, University Hospital, St. Joseph's Hospital and Medical Center, and Cooper Hospital/University Medical Center). Under this application, Newark Beth Israel Medical Center is proposed as a new subunit for conducting pediatric and perinatal clinical trials. Funding from NIAID will be by subcontract, covering research personnel at UMD/NJMS, Children's Hospital of NJ and St. Joseph's Hospital Medical Center, while Cooper Hospital/university Medical Center and the proposed NBI will be supported on a per-patient cost reimbursement basis for the first year of funding. Each site will have the opportunity to enroll HIV infected patients from their catchment area into this national network of clinical trials. Children's Hospital of NJ and Cooper Medical Center will enroll only infants, children and youths while University Hospital, St. Joseph and Newark Beth Israel will participate in enrollment of pediatric patients and pregnant women into perinatal clinical trials. The principal investigator, Dr. James Oleske, is overall responsible for the operation of this funded application. Dr. George McSherry is the medical director director and principal pediatric co-investigator, Dr. Arlene Bardeguez is the principal periantal co-investigator, Dr. Deborah Storm is study coordinator; each clinical subunit has a pediatric and/or perinatal investigator, study nurse, and pharmacy support. The overall goal is to enroll a total of 60 new HIV infected patients into national clinical trials which will include pregnant women, their infants, children and youth.
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