PHASE I/II, OPEN-LABEL, PHARMACOKINETIC AND SAFETY STUDY OF A NOVEL PROTEASEO

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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 P1020-A is a phase I/II, open-label multicenter study of BMS-232632 as part of combination antiretroviral regimens. The availability of a powder formulation and once-daily dosing makes BMS-232632 an attractive agent for inclusion in pediatric regimens. The PACTG P1020-A study will determine the pharmacokinetic profile and dosing schedule of the capsule formulation for BMS-232632 in combination with two NRTIs, determine the pharmacokinetic profile and dosing schedule for the powder formulation in combination with two NRTIs, and determine the safety and tolerability of BMS-232632 in HIV-infected infants, children, and adolescents.