We propose to establish, in New York City, The New York Pediatric Upper West Side AIDS Clinical Trials Unit Consortium. This Consortium is composed of the following sites: Babies Hospital, Harlem Hospital, Incarnation Children's Center (ICC), and St. Luke's Roosevelt Hospital. The Consortium is located in an epicenter of the HIV epidemic, and as such can provide access to ACTG protocols to over 100 new HIV-infected women, infants, and children per year. The PIs and other researchers at each institution are seasoned investigators in AIDS clinical trials, and each is a full time faculty member at the Columbia University College of Physicians and Surgeons. They provide a stimulating mix of talent and interests, in that some are specialists in Pediatric Infectious Diseases and others are Primary Care Physicians. There is not only an ACTG-certified immunology and virology laboratory at Babies to which all specimens will be sent, but there are also a group of established and independently funded investigators with interests in basic research on HIV, who will provide a critical mass for the development of new ideas in approaches to prevent and treat HIV infections. At Babies Hospital the interweaving of staff involved in NIH-supported HIV studies of viral transmission from women to their offspring (WITS) and in ACTG clinical trials provides a unique opportunity for rollover of patients from one HIV study into another, thus resulting in a high level of access to women and children in ACTU protocols. The representative patient population served by the hospitals of the Consortium is largely impoverished, from minority groups, and socially disadvantaged. This population is hardest hit by the AIDS epidemic. Access to highly specialized tertiary care facilities at Babies Hospital provides an impetus for the other institutions with large numbers of HIV-infected women and children to join with Babies Hospital to create the Consortium. For the past year, staff at the Babies site and at ICC have worked together synergistically to enroll a large number of patients into ACTU protocols (2nd quartile in Pediatric ACTG enrollment for 1992). Formation of the Consortium will provide greater access to patients, an outstanding level of medical competence, and interaction of basic researchers with academic physicians engaged in ACTG clinical trials, which should lead to a high degree of productivity in research on the prevention and treatment of HIV infection.
