Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy.

AIDS
Tim R CresseyPHPT-5 Team

Abstract

To evaluate the pharmacokinetics and HIV viral load response following initiation during the third trimester of pregnancy of zidovudine plus standard-dose lopinavir boosted with ritonavir (LPV/r), twice daily, until delivery for the prevention of mother-to-child transmission of HIV. Prospective study nested within a multicenter, three-arm, randomized, phase III prevention of mother-to-child transmission of HIV trial in Thailand (PHPT-5, ClinicalTrials.gov Identifier: NCT00409591). Women randomized to receive 300 mg zidovudine and 400/100 mg LPV/r twice daily from 28 weeks' gestation, or as soon as possible thereafter, until delivery had intensive steady-state 12-h blood sampling performed. LPV/r pharmacokinetic parameters were calculated using noncompartmental analysis. Rules were defined a priori for a LPV/r dose escalation based on the proportion of women with an LPV area under the concentration-time curve (AUC) below 52 microg h/ml (10th percentile for LPV AUC in nonpregnant adults). HIV-1 RNA response was assessed during the third trimester. Thirty-eight women were evaluable; at entry, median (range) gestational age was 29 (28-36) weeks, weight 59.5 (45.0-91.6) kg, CD4 cells count 442 (260-1327) cells/microl and HIV-1 RNA v...Continue Reading

References

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Citations

Sep 29, 2012·Clinical Pharmacokinetics·Kajal BuckoreelallJennifer R King
Feb 14, 2013·Drugs·Nisha Andany, Mona R Loutfy
Nov 16, 2011·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Tim R CresseyUNKNOWN IMPAACT P1026s Team
Nov 13, 2014·Expert Opinion on Drug Safety·Marilia Santini-Oliveira, Beatriz Grinsztejn
Nov 14, 2014·Clinical Drug Investigation·Elena López AspirozAlfonso Domínguez-Gil Hurlé
Oct 11, 2017·Expert Review of Clinical Pharmacology·Robert Pope, Angela Kashuba
Mar 10, 2016·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Nuggehally R Srinivas

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