This application is for continuation of a Pediatric AIDS Clinical Trials (ACTU) at Columbia University, for years 10-14 of the project. The Unit has two components, the main unit at Babies Hospital, in the Women and Children's Care Center (WCCC) and a subunit Incarnation Children's Center (ICC) a residential center that provides respite, hospice and clinical care for HIV infected children many of whom are in foster care. This ACTU is located is located in the Upper West Side of New York City in a geographic location of high prevalence of HIV infection, especially in women and children. The PIs and other researchers are seasoned investigators in AIDS clinical trials and each is a full time member of the faculty at Columbia University College of Physicians and Surgeons. There is a Pediatric HIV-certified ACTG virology laboratory on site. At Babies Hospital the interweaving of staff involved in NIH-supported HIV studies of viral transmission of HIV from women into their offspring (WITS) and 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 ACTG protocols. The representative patient population served by the two institutions are largely impoverished, from minority groups, and socially disadvantaged. For the past five years, staff at the Babies Hospital and ICC have worked together synergistically to enroll a large number of patients into ACTG protocols. On average, we have enrolled 18 new HIV-infected children into protocols annually in the past. We have also enrolled many children into multiple protocols so that over the past 9 years our patient accrual has been more than 250 enrollments. In the current year we have already enrolled have more patients above out originally planned accrual. With the local presence of the WITS study and a newly forged relationship with Harlem Hospital Department of Obstetrics, we anticipate significantly greater enrollment of HIV-infected women into perinatal studies. Based on our past performance at what we believe has been an outstanding level of regarding accrual, data management, compliance with regulatory requirements, and significant contributions to the research agenda of the ACTG, we are respectfully requesting that our unit be funded in order to perform future research studies. Our plans for the future are to concentrate our efforts on perinatal studies and Phase 1 primary antiretroviral studies in women, infants and children. We further hope to establish a program for adolescents. We will also participate to the fullest of our resources in protocols that address means to prevent and treat opportunistic infections and to record information regarding long term outcomes of HIV-infected patients. We believe that our ACTU provides significant access to patients and in turn offers an outstanding an outstanding level of medical competence, an outstanding staff whose aim is not only to provide compassionate medical care to HIV-infected patients but also to perform meaningful and useful research on prevention and treatment of HIV.
