ACTG A5223: SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS

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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 study hypothesizes that women achieve higher lopinavir (LPV) drug levels than do men on similar doses of LPV and ritonavir (RTV). The primary objective is to compare the pharmacokinetic (PK) parameter, area under the concentration-time curve (AUC) of LPV between HIV-1-infected men and women currently receiving similar doses of LPV/RTV. PK evaluations will be performed on plasma samples obtained prior to and up to 12 hours after the administration of the morning dose of LPV/RTV in 78 evaluable subjects (39 men and 39 women) currently managed on LPV/RTV as part of their antiretroviral regimen. A screening visit will occur within 30 days prior to the PK visit. Upon confirmation of eligibility, subjects will return for a registration/entry visit to enroll into the study and will be given a 48-hour medication diary to complete. Subjects will be required to spend approximately 13 hours at the GCRC for the intensive PK blood sampling. Subjects will be > 18 years old and currently receiving LPV/RTV (lopinavir 400 mg/ritonavir 100 mg po bid) plus one or more of the following: nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir (a nucleotide RTI), and enfuvirtide (a fusion inhibitor). Subjects must be on the same regimen for at least 14 days prior to screening. Subjects will be stratified by race/ethnicity. This study may lead to increased power and generalizability of findings in men; preliminary studies suggest differences in PK, side effects, and therapeutic effects in women.