The objective of this proposal is to develop a comprehensive chemotherapy program to assess therapies directed against HIV infection in children. Our long term goals are to provide treatment for all children and to develop strategies for prevention of disease in children.
The specific aims of this proposal are: 1.) to develop a program that will provide for efficient and effective assessment of the efficacy and toxicity of both antiviral drugs and other agents directed against HIV and its complications: 2.) to provide expertise and assistance In protocol development for evaluation of new agents on a timely basis; 3.) to develop a registry for rapid patient identification and efficient accrual into chemotherapy trials; and 4.) to conduct trials in all phases of study from inception to Phase 3 protocols. The number of cases of AIDS in children has continued to increase, with Florida ranking third nationally in the number of pediatric AIDS cases reported. The University of Miami/Jackson Memorial Hospital Medical Center has studied over 200 patients with pediatric AIDS and presently follows 120 HIV-infected children. An integrated pediatric program with a strong emphasis on clinical and basic science research in the area of pediatric HIV infection has already been developed and is in place to support the proposed program. A major goal of the clinical is the prevention of HIV-infection and the provision of treatment for children. Prospective studies of infants born to HIV seropositive are currently in progress and provide a readily available population of patients for early identification of infected infants and potential study recruitment. Outpatient and inpatient facilities have been developed for the care and followup of these children. Laboratory facilities for HIV serology and virology, immunologic determinations related to AIDS and pharmacologic assays are readily available at our center and are headed by personnel with prior experience in both adult and pediatric HIV drug treatment protocols. Our group has experience in designing and carrying both Phase 1 and Phase 2 multicenter collaborative clinical trials of AZT. This proposal will bring a new dimension to the treatment of pediatric AIDS at our center and adds perspective to the ongoing research studies.
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