CLINICAL TRIAL: EFFECT OF PREGNANCY ON THE PHARMACOKINETICS OF THE KALETRALO

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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. The purpose of this study is to better understand how to dose antiretroviral agents in HIV-infected women during pregnancy. This study will compare exposures of both protein-unbound and total (protein bound + protein unbound) lopinavir/ritonavir (Kaletra¿) concentrations in the second and third trimesters of pregnancy, and before and after an empiric dosage increase in lopinavir/ritonavir in the third trimester. HIV-infected pregnant women receiving lopinavir/ritonavir as a component of antiretroviral treatment will participate. This open-label, non-blinded pharmacokinetic (PK) study will require subjects to undergo 3 or 4 intensive 12 hour pharmacokinetic visits in the UNC General Clinical Research Center (GCRC). The first visit will occur at approximately 20 weeks? gestation (second trimester), the second at 30 weeks (third trimester, using standard Kaletra¿ dosing), and the third at 32 weeks gestation (third trimester, after a dose increase in Kaletra¿). At two weeks post-partum, the Kaletra¿ dose will be reduced to the standard regimen. An optional 6-12 week postpartum PK visit will be offered.