A5223: SEX DIFFERENCES IN LPV/RTV IN HIV INFECTED MEN AND WOMEN

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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 the first large prospective study of sex differences in the PK of LPV/RTV conducted in HIV-1-infected individuals. There will be intensive PK sampling and measures incorporated to reduce potential confounders due to differences in rate of compliance among the different groups. In addition, the effect of race/ethnicity on antiretroviral PK has the potential of being a confounder in the current study. In order to address this, the study proposes to stratify both male and female groups by race/ethnicity. The background regimen for subjects entering the study is standardized. Subjects on LPV/RTV with one or more of the following: NRTIs, tenofivir (TDF) and enfuvirtide (ENF), will be eligible to be included in the study. These drugs will not be provided by this study. It is hypothesized that women achieve higher LPV drug levels than do men on similar doses of LPV/RTV. In this study 78 men and women of various ethnicities between 18-64 years of age will be recruited. The subjects will have documented HIV infection and will have received LPV/RTV and combinations, for at least 14 days prior to the screening visit, will demonstrate defined laboratory values and will weigh more than 50kg. At MetroHealth, 4 subjects will be enrolled. Subjects will be required to spend approximately 13 hours at the General Clinical Research Center.