Lallemant Marc auteur aut IRD Le Coeur Sophie auteur aut IRD Sirirungsi W. auteur aut IRD Cressey T. R. auteur aut IRD Ngo-Giang-Huong Nicole auteur aut IRD Traisathit P. auteur aut IRD Klinbuayaem V. auteur aut IRD Sabsanong P. auteur aut IRD Kanjanavikai P. auteur aut IRD Jourdain Gonzague auteur aut IRD McIntosh K. auteur aut IRD Koetsawang S. auteur aut IRD Phpt- Study Investigators auteur aut IRD text journalArticle eng text/pdf born digital access Objectives:Perinatal single-dose nevirapine (sdNVP) selects for resistance mutations. The objective of this trial was to compare two maternal sdNVP-sparing regimens with standard zidovudine (ZDV)/sdNVP prophylaxis.Design:PHPT-5 was a randomized, partially double-blind placebo-controlled, noninferiority trial in Thailand (NCT00409591). Study participants were women with CD4(+) of at least 250cells/l and their infants.Methods:All women received ZDV from 28 weeks' gestation and their newborn infants for one week. Women were also randomized to receive NVP-NVP (reference): maternal intrapartum sdNVP with a 7-day tail' of ZDV along with lamivudine, and infant NVP (one dose immediately, another 48h later); infant-only NVP: maternal placebos for sdNVP and the tail', with infant NVP; LPV/r: maternal LPV/r starting at 28 weeks. Infants were formula-fed. HIV-diagnosis was determined by DNA-PCR.Results:Four-hundred and thirty-five women were randomized between January 2009 and September 2010. Accrual was terminated prematurely following a change in Thai guidelines recommending antiretroviral combination therapy for all pregnant women. Data on 405 mothers and 407 live-born children were analyzed. Baseline characteristics were similar between arms. Intent-to-treat transmission rates were 3.8% (95% confidence interval: 1.2-8.6) in NVP-NVP, 1.6% (0.2-5.6) in infant-only NVP, and 1.4% (0.4-5.1) in LPV/r arms. As-treated rates were 2.2% (0.5-6.4), 3.2% (0.9-7.9), and 1.5% (0.2-5.2), respectively. Factors independently associated with transmission were prophylaxis duration less than 8 weeks (adjusted odds ratio 15.5; 3.6-66.1) and viral load at baseline at least 4log(10)copies/ml (adjusted odds ratio 10.9; 1.3-91.5). Regimens appeared well tolerated.Conclusion:Transmission rates in all arms were low but noninferiority was not proven. Antiretroviral prophylaxis for at least 8 weeks before delivery is necessary to minimize transmission risk. specialized antiretroviral therapy clinical trial HIV prevention of mother-to-child transmission Thailand THAILANDE 052 050 29 18 2497-2507 2015 0269-9370 https://www.documentation.ird.fr/hor/fdi:010066091 10.1097/qad.0000000000000865 0269-9370 [F B010066091] https://www.documentation.ird.fr/hor/fdi:010066091 https://www.documentation.ird.fr/intranet/publi/2016/02/010066091.pdf Accès réservé (Intranet de l'IRD) IRD - Base Horizon / Pleins textes 2016-02-26 2017-08-23 fdi:010066091 fre