The specific aim of this application is the development of a Pediatric AIDS Clinical Trial Unit (PCTU) at Boston City Hospital. The establishment of a PCTU would complement the on-going activities in surveillance, counselling, early diagnosis, and clinical evaluation of children with HIV infection. The existing program for children with HIV infection at Boston City Hospital has documented number of patients which will be seen in each year; has expertise in design and implementation of clinical studies requiring the longitudinal evaluation of patients, has expertise and experience in maintaining high risk urban, minority patients in a therapeutic program and has a number of investigators. Collaborative programs with established laboratories for HIV culture and antigen testing have been developed. A clinical trial unit will function in cooperation with ongoing funded programs which identify high risk, pregnant women seeking prenatal care within Health and Hospitals. These programs will provide the opportunity to enroll infants as soon as criteria for HIV infection in the newborn have been established. The clinical program for infants with HIV infection will utilize existing expertise to establish a multidisciplinary approach. Primary and consultative care, nursing, and support personnel including social work, outreach workers and nutritionists will provide services for the patient and family. In order to maximize our longitudinal follow- up of high risk children, we present a protocol for the evaluation of ribavirin for therapy of symptomatic HIV disease. The experimental protocol provides for entry criteria, informed consent, evaluation of ribavirin pharmacokinetics monitoring of toxicity, and evaluation of clinical, immunologic and virologic outcomes and on-site data entry and management. We recognize that funding will be part of the NIAID cooperative program and experimental protocols will be developed within the ACTU structure.
