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, open-label three part pharmacokinetic study in healthy subjects. This study will examine the pharmacokinetic interactions between ATV and Kaletra (LPV/RTV) when the two are co-administered. Twenty-four hour pharmacokinetic profiles will be obtained following dose administration on days 10, 24, and 34. Trough drug concentrations will also be obtained at specified times throughout the study. Safety assessments (physical examination, vital sign measurements, 12-lead electrocardiogram, and clinical laboratory tests) will be performed at screening, during the study and prior to discharge. Subjects will be continuously monitored for adverse events throughout the duration of the study. Beginning on day 1, subjects will receive a combination of ATV 300mg QAM plus RTV 100mg QAM for 10 days (day1-10). On day 11, subjects will be switched to a combination of ATV 300mg QAM plus Kaletra (LPV/RTV 400mg/100mg) BID for 14 days (day 11-24). On day 25, subjects will be switched to a combination of ATV 300mg QAM plus RTV 100mg QAM plus Kaletra (LPV/RTV 400mg/100mg) BID for 10 days (day 25-34).
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