SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS IN HIV-1 INF MEN & 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. The hypothesis is that women achieve higher lopinavir drug levels than men do on similar doses of lopinavir/ritonavir. The primary objective is to compare the PK parameter, area under the concentration-time curve (AUC) of lopinavir between HIV-1 infected men and women currently receiving similar doses of lopinavir/ritonavir. Pharmacokinetic (PK) evaluations will be performed on plasma samples obtained prior to and up to 12 hours after the administration of the morning dose of lopinavir/ritonavir (LPV/RTV) in 78 evaluable subjects (39 men and 39 women) currently managed on LPV/RTV as part of their antiretroviral regimen. Seventy-eight HIV-infected subjects, 39 men and 39 women, age greater than or equal to 18 years currently receiving LPV/RTV (lopinavir 400 mg/ritonavir 100 mg by mouth twice a day) plus one or more of the following: nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir (a nucleotide TRI), and enfuvirtide (a fusion inhibitor). Subjects must be on the same regimen for at least 14 days prior to screening.