Influence of diabetes on pharmacokinetics of lopinavir in HIV-infected women during pregnancy and at delivery

Abstract

Lopinavir (LPV) is currently one of the most commonly used protease inhibitors in pregnant women with HIV. The aim of the study is to evaluate the influence of diabetes mellitus (DM) on the pharmacokinetics of lopinavir in HIV-infected women during the third trimester of pregnancy, at delivery and in umbilical cord. Nondiabetic HIV-infected women during the third trimester of pregnancy (control group, n = 8) and diabetic HIV-infected women during the third trimester of pregnancy (n = 8), treated with 133.3 mg lopinavir and 33.3 mg ritonavir (1 capsule of Kaletra®, Abbott) every 12 h, will be investigated. Serial maternal blood samples will be collected at steady state during the dose interval of 12 h. At delivery, will also be collected simultaneously blood samples from maternal women and umbilical cord, as well as a sample of amniotic fluid. Plasma concentrations of total and free lopinavir will be analysed by LC-MS/MS. Pharmacokinetic parameters will be evaluated using the WinNonlin software. The influence of diabetes on the pharmacokinetics of lopinavir in HIV-infected women during pregancy will be evaluated using the Mann-Whitney two-tailed unpaired test, pd 0.05.