PACTG P1026S: PK PROPERTIES OF ANTIRETROVIRAL DRUGS DURING 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. P1026S is a phase I study of HIV-infected pregnant women who are already receiving, as part of their clinical care, nevirapine 200 mg b.i.d., amprenavir 1200 mg b.i.d., abacavir 300 mg b.i.d., lopinavir/ritonavir 400/100 mg b.i.d., or the off-label dosing combination of indinavir/ritonavir 800/100 mg b.i.d since these important and commonly used drug combinations in pregnant women lack PK data. 25 subjects per drug/drug combination or a total of 125 women participating in PACTG P1025 will be enrolled into this prospective PK substudy. PK evaluation will be performed antepartum, intrapartum, and postpartum. If drug levels are found to be inadequate, dose adjustments may be made. This study will describe PK parameters during pregnancy of these drugs and determine if therapeutic dosing regimens produce adequate drug exposure during pregnancy.