ANTIRETROVIRAL DRUGS DURING PREGNANCY, SUBSTUDY OF PACTG P1025

这个子项目是众多研究子项目之一

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 pharmacokinetics (PK) study to evaluate the pharmacokinetics of currently prescribed antiretroviral (ARV) drugs and interacting combinations of these drugs in pregnant HIV-infected women. Subjects can enroll at or equal to 26 weeks gestation. Subjects must be enrolled in PACTG protocol 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 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. The study objectives are: -To describe the PK parameters during pregnancy of selected antiretroviral drugs currently used in the clinical care of pregnant HIV-infected women, and to determine if therapeutic dosing regimens of these antiretroviral drugs produce adequate drug exposure during pregnancy compared to a) historical data from non-pregnant adults; and b) the same women in the study cohorts during the postpartum period. -To compare antiretroviral drug concentrations in plasma from cord blood with those in maternal plasma at the time of delivery. -To indirectly assess the induction of cytochrome P450 3A4 by determining the ratio in urine of 6B-hydroxycortisol to cortisol. 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. Glucocorticoid metabolism will be evaluated in each subject on each PK sampling day by measurement of urine concentrations of 6B-hydroxycortisol and cortisol. Subjects will continue to take their prescribed medications throughout their pregnancy.