PEDIATRIC AIDS CLINICAL TRIALS GROUP

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A pediatric AIDS Clinical Trials Unit (PACTU) is proposed for St. Jude Children's Research Hospital with subunits at the University of Tennessee, (Le Bonheur Children's Medical Center and The Med), the Methodist Hospital and Vanderbilt University Medical center. The objective is to support the scientific agenda of the coordinating and Operations Center (CORC) proposed by Spector et al. and the NIAID) HIV/AIDS research agenda set forth in 1995. The team off the proposed PACTU includes well established academic specialists in pediatric and adult infectious diseases, immunology, pharmacology, virology, pharmaceutical science, pediatric neurology, psychology, neonatology, fetal and maternal medicine, vaccinology, oncology and gene transfer- based therapy. Each of the three children's hospitals have ongoing clinics for pediatric AIDS and the hospitals provide three separate obstetrical and neonatal programs with experience in maternal and infant AIDS. Over the past five years the St. Jude PACTU has demonstrated excellence as an innovative, productive, interactive site for the AUG program of the NIAID). We now plan to build on the existing program by addition of esteemed colleagues, state-of-the-art facilities and expanded clientele of HIV-infected infants, children and women at Vanderbilt University. This, in turn, provides access for all HIV- infected children throughout Tennessee and its seven bordering states to ACTG protocols and experimental drugs and vaccines. The high density population of African-Americans in the mid-South and the rapid increase of HIV infection in adolescents of this group assure an ample sample of HIV-infected pregnant women and their infants, as well as non- pregnant adolescents for study. Because of the strength of our experience in pharmacology, phrmacokinetics and new drug development we intend to take a major role in phase I and I/II studies of new compounds. A second major emphasis will be on HIV-infected adolescents because of unique features of these older pediatric patients, the prevalence of these individuals in our catchment area and our well established collaboration with specialists in internal medicine who share our, interest in AIDS research.