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Title: Randomized noninferiority trial of two maternal single-dose nevirapine-sparing regimens to prevent perinatal HIV in Thailand
Authors: Marc Lallemant
Sophie Le Coeur
Wasna Sirirungsi
Tim R. Cressey
Nicole Ngo-Giang-Huong
Patrinee Traisathit
Virat Klinbuayaem
Prapan Sabsanong
Prateep Kanjanavikai
Gonzague Jourdain
Kenneth McIntosh
Suporn Koetsawang
Institute of research for development, Thailand
Harvard School of Public Health
Chiang Mai University
INED Institut National d' Etudes Demographiques
Thailand Ministry of Public Health
Banglamung Hospital
Children's Hospital Boston
Mahidol University
Keywords: Immunology and Microbiology
Issue Date: 1-Jan-2015
Citation: AIDS. Vol.29, No.18 (2015), 2497-2507
Abstract: © 2015 Wolters Kluwer Health, Inc. All rights reserved. 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 250 cells/ml 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 48 h 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 4 log10copies/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.
ISSN: 14735571
Appears in Collections:Scopus 2011-2015

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