PEDIATRIC AIDS CLINICAL TRIALS UNIT

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The goal of the University of Washington (UW) pediatric ACTU faculty is to perform exemplary HIV/AIDS treatment research in outpatients and inpatients as part of the national multicenter AIDS Clinical Trials Group (ACTG). The UW Pediatric ACTU's specific aims are to conduct Phase I, II and III studies in these areas: 1) primary pediatric infection; 2) opportunistic infections; and 3) perinatal trials. An additional aim is conduct of studies of opportunistic infections, especially genital infections with potential complications such as cervical cancer in women. We have an established investigative team including pediatrics, obstetrics, gynecology and internal medicine, experienced in performing antiviral and other clinical trials in pregnant women, infants and children. The UW is the referral center for a five-state region of the Pacific Northwest for HIV in children and pregnant women, and has followed 90 children and over 70% of the HIV seropositive pregnant women in this region. The states of Washington and Oregon have experienced a 40% increase in HIV seroprevalence in pregnant women from 1989 to 1990, and this increase has occurred mainly in ethnic minorities. Total minority numbers are 36% African American, 21 % Native American, 3% Hispanic and 2% Asian. We have established the Northwest Family Center (NWFC), a "one-stop-shopping" facility with a multicultural staff to provide clinical care, social support and access to ACTG clinical trials. As substance abuse was the mechanism of HIV infection in 80% of seropositive pregnant women, NWFC has co-located with a treatment program for chemically dependent pregnant women. We have the infrastructure to enroll and retain HIV infected pregnant women and their infants, as well as HIV infected children, on ACTG protocols in a culturally sensitive fashion. We will enroll at least 35 HIV infected pregnant women and their infants as well as 28 HIV infected children per year in clinical trials. This proposal seeks funding to achieve independent status as a Pediatric ACTU and establishment of the Oregon Subunit.