Cressey T. auteur aut IRD Jourdain Gonzague auteur aut IRD Rawangban B. auteur aut IRD Varadisai S. auteur aut IRD Kongpanichkul R. auteur aut IRD Sabsanong P. auteur aut IRD Yuthavisuthi P. auteur aut IRD Chirayus S. auteur aut IRD Ngo-Giang-Huong Nicole auteur aut IRD Voramongkol N. auteur aut IRD Pattarakulwanich S. auteur aut IRD Lallemant Marc auteur aut IRD text journalArticle eng text/pdf born digital access Objective: 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. Design: 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). Methods: Women randomized to receive 300mg zidovudine and 400/100mg 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 mu g h/ml (10th percentile for LPV AUC in nonpregnant adults). HIV-1 RNA response was assessed during the third trimester. Results: 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/mu l and HIV-1 RNA viral load 7818 (<40-402 015) copies/ml. Geometric mean (90% confidence interval) LPV AUC, C-max and C-min were 64.6 (59.7-69.8) mu g h/ml, 8.1 (7.5-8.7) mu g/ml and 2.7 (2.4-3.0) mu g/ml, respectively. Thirty-one of 38 (81%) women had an LPV AUC above the AUC target. All women had a HIV-1 viral load less than 400 copies/ml at the time of delivery. Conclusion: A short course of zidovudine plus standard-dose LPV/r initiated during the third trimester of pregnancy achieved adequate LPV exposure and virologic response. specialized lopinavir pharmacokinetics pregnancy prevention of mother-to-child transmission of HIV viral load 052 24 14 2193-2200 2010 0269-9370 https://www.documentation.ird.fr/hor/fdi:010091862 10.1097/QAD.0b013e32833ce57d 0269-9370 [F B010091862] https://www.documentation.ird.fr/hor/fdi:010091862 https://www.documentation.ird.fr/intranet/publi/2024-11/010091862.pdf Accès réservé (Intranet de l'IRD) IRD - Base Horizon / Pleins textes 2010-10-01 2024-11-15 fdi:010091862 fre