PEDIATRIC AIDS CLINICAL TRIALS UNIT

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The Chicago Pediatric AIDS Clinical Trials Unit has enrolled 134 patients in AIDS Clinical Trials Group Protocols during its four years of existence. Most of the patients have been enrolled in protocols evaluating antiretroviral therapy in different stages of HIV disease in children. We have a special interest in phase I/II protocols as evidenced by our ability to enroll 30 patients in five protocols. To increase participation of HIV-infected pregnant women in perinatal protocols, we are proposing to establish a subunit at the University of Illinois which conducts the Women/Children Transmission Study (WITS) in Chicago. The current successful efforts of WITS to recruit and retain HIV-infected pregnant women assures an increase in enrollment of these women to perinatal studies. Our goal is also to participate in protocols involving opportunistic infections and evaluation of immune-based therapy including vaccines. The proposed four units of the Chicago consortium are located in different parts of the city which will help us to effectively reach most of the families known to be affected by the AIDS epidemic in Chicago. We have also applied for funds to establish a virology and immunology component which will address questions unique to the pediatric ACTG protocols. In addition, funds are requested to enable us to participate in the pharmacological aspects of the Pediatric ACTG protocols. We are applying for funds to support our efforts 1) to enroll 70 new patients per year in ACTG protocols and 2) to transfer 8 patients per year to new protocols upon completion of their original protocol. In addition, the requested funds will assure a smooth continuation of followup on 94 patients who are already participating in ACTG protocols. In part C of the application we request funds for developmental research in virology (C-1), immunology (C-2) and neuropsychological assessment (C-3).