This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PACTG 1020-A is a Phase I/II, national and international, multicenter, open-label study of BMS-232632 (atazanavir) and BMS-232632 + ritonavir-containing combination therapies for ART-naive and -experienced patients. Children and adolescents (152 subjects) from the age 91 days to 21 years will be enrolled into the study. The primary endpoint is to determine the pharmacokinetic profile and optimal dosing schedule of the capsule and powder formulations of BMS-232632 and BMS-232632 + ritonavir in combination with two NRTIs in HIV-infected children and adolescents. PACTG 1020-A is designed to determine appropriate doses of BMS-232632 and BMS-232632 + ritonavir for four strata, defined with respect to age and BMS-232632 formulation, and country of enrollment (U. S. or South Africa). During the study, the safety and tolerance of BMS-232632 will be closely monitored, and preliminary virologic efficacy data will be obtained. The observed dose-dependent QTc and PR prolongation found in AI424-040 BMS study warrant continued ECG monitoring in PACTG 1020A. A larger clinical experience will allow an assessment of the clinical significance of these findings. The availability of a powder formulation and the once-daily dosing schedule makes BMS-232632 an attractive agent for inclusion in pediatric treatment regimens. Detailed pharmacokinetic data are needed as young children have had approximately 2-fold higher rate of hepatic clearance versus adults for some protease inhibitors.
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