This application is for continuation of a Pediatric AIDS Clinical Trials Unit (PACTU) at Columbia University. This Unit has 3 components, the main unit at Columbia in the Women and Children's Care Center (WCCC), a subunit Incarnation Children's Center (ICC), and a new subunit at the Cornell facility of New York-Presbyterian Hospital. The main unit of this PACTU 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 Cornell site is following a significant number of HIV-infected adolescents. The principal investigators (PIs) and other researchers at all sites 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 or Cornell University. There is a Pediatric HIV-certified ACTG virology laboratory on site at Columbia. At WCCC the interweaving of staff involved in NIH-supported HIV studies of viral transmission of HIV from women to 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 PACTG protocols. The representative patient population served by all sites are largely impoverished, from minority groups, and socially disadvantaged. For the past 12 years, we have enrolled a large number of patients into ACTG protocols, on average 50 subjects annually into protocols in the past 5 years. Over the past 12 years our patient accrual has been more than 450 enrollments. With the local presence of the WITS study, we anticipate significant enrollment of HIV-infected women into perinatal studies. Based on our past performance with regard to 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 for future studies. We have competent, 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 infection.
