AIDS CLINICAL TRIALS

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The prevalence of pediatric AIDS is rapidly escalating in the Mid-South; during 1988 to 1990 the prevalence of perinatal AIDS reached rates comparable to those in California, Texas, Illinois and Michigan. Two factors account for the relatively high rate of perinatal AIDS in the Mid- South: the high prevalence of HIV in young African-American women and the large population of this risk group in the South. The prevalence of HIV infection in African-American women of childbearing age is about tenfold higher than in corresponding white women, both nationally and locally. Memphis has the 9th largest urban black population in the U.S. and the adjoining states of Mississippi, Tennessee and Arkansas rank 1st, 10th and 11th, respectively, in proportion of African-American residents among the states. St. Jude Children's Research Hospital is a major pediatric cancer center. Three years ago a research program in pediatric AIDS was started and has been successful in completion of phase I and II studies of anti-HIV and anti-P. carinii agents. Some of these studies involved collaboration with The Regional Medical Center (The Med) and Le Bonheur Children's Medical Center. The current proposal is to build upon the existing ongoing multi- disciplinary program and to establish a pediatric ACTU centered at St. Jude with research subunits at The Med and Le Bonheur. This center will participate in the national pediatric ACTU network. Patients will be enrolled in maternal-infant transmission studies and phase I, II and III protocols for HIV and opportunistic infections. Phase I studies will have high priority. The catchment area will serve patients within a radius of about 300 miles from Memphis, a region otherwise without access to experimental drugs for HIV infection. Among the unique strengths of the proposed pediatric ACTU are its location at a leading and the world's largest pediatric cancer research center; a large contingent of pediatric infectious disease specialists highly experienced in designing and conducting clinical trials in immunocompromised children; an environment fostering interaction of physician-scientists and basic scientists; remarkably low attrition rates for clinical trials, including trials in AIDS patients; ancillary support anchored by the resources and experienced personnel at St. Jude, The Med and Le Bonheur; and access to a large, underserved minority population in the Mid-South.