PHARMACOKINETIC & SAFETY STUDY OF PROTEASE INHIBITOR IN COMB IN HIV INFECTED

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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. This is a Phase I/II multi-center investigation being conducted at PACTG sites throughout the US and at the PACTG site in Soweto, South Africa. PACTG 1020-A is designed to provide pharmacokinetic (PK) data to guide dosing recommendations for BMS-232632 (ATV, atazanavir, Reyataz+) in infants, children, and adolescents. This means that the study will look specifically at how the body absorbs, distributes, metabolizes and excretes the drug. PACTG 1020-A is the first step in establishing the appropriate dosing for this new protease inhibitor in the pediatric population. BMS-232632 is a novel protease inhibitor (PI), licensed for use in adults that can be given once a day. The once daily dosing is a distinct advantage for BMS-232632 in the global fight against HIV infection. Easier to follow antiretroviral regimens may improve adherence. The other advantage of this PI is its lack of effect on cholesterol and triglyceride levels. This study has been ongoing since 2000. Part A included subjects given BMS-232632 without a ritonavir boost. Only the subjects in South Africa will participate in step II of the study, so this report will not address step II.