PACTG P1026S PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL DRUGS IN PREGNANCY

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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 a prospective pharmacokinetic study to evaluate the pharmacokinetics of currently prescribed antiretroviral drugs and interacting combinations of these drugs in pregnant HIV-infected women. Subjects can enroll at >26 weeks gestation. Subjects must be enrolled in P1025 and currently receiving one of the following antiretroviral drugs or interacting combinations at adult dosing: nevirapine 200 mg b.i.d., amprenavir 1200 mg b.i.d., abacavir 300 mg bid.,lopinavir/ritonavir 400/100 mg b.i.d., or the off-label dosing combination of indinavir/ritonavir 800/100 mg bid. The drugs/combinations selected for study in this protocol were among those most commonly used in PACTG 367 database that lacked pharmacokinetic data during pregnancy. Twenty-five pregnant women receiving each drug or combination will be enrolled in the protocol, for a total enrollment of 125 women. Pregnant women participating in the study will have intensive PK sampling performed during the third trimester of pregnancy and again between 6 and 12 weeks postpartum. On the day of PK sampling, the study visit should be scheduled to start in the morning and to coincide with the end of the previous dosing cycle. Each subject will have a blood sample collected and then will be given the next dose of study medication in the clinic. Subjects will remain in the clinic until the completion of PK sampling on study days.