SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS AMONG HIV-1-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. A5223 is a prospective evaluation of 78 (39 men and 39 women) HIV-1-infected subjects designed to determine the pharmacokinetics (PK) of lopinavir (LPV) in men and women ?18 years of age. Subjects must be currently receiving 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. The 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 to be given a 48-hour medication diary. Subjects will be required to spend approximately 13 hours in the GCRC for the intensive PK blood sampling.