Puthanakit T. auteur aut IRD Saphonn V. auteur aut IRD Ananworanich J. auteur aut IRD Kosalaraksa P. auteur aut IRD Hansudewechakul R. auteur aut IRD Vibol U. auteur aut IRD Kerr S. J. auteur aut IRD Kanjanavanit S. auteur aut IRD Ngampiyaskul C. auteur aut IRD Wongsawat J. auteur aut IRD Luesomboon W. auteur aut IRD Ngo-Giang-Huong Nicole auteur aut IRD Chettra K. auteur aut IRD Cheunyam T. auteur aut IRD Suwarnlerk T. auteur aut IRD Ubolyam S. auteur aut IRD Shearer W. T. auteur aut IRD Paul R. auteur aut IRD Mofenson L. M. auteur aut IRD Fox L. auteur aut IRD Law M. G. auteur aut IRD Cooper D. A. auteur aut IRD Phanuphak P. auteur aut IRD Vun M. C. auteur aut IRD Ruxrungtham K. auteur aut IRD text journalArticle eng text/pdf born digital access Background The optimum time to start antiretroviral therapy for children diagnosed with HIV infection after 1 year of age is unknown. We assessed whether antiretroviral therapy could be deferred until CD4 percentages declined to less than 15% without affecting AIDS-free survival. Methods In our multicentre, randomised, open-label trial at nine research sites in Thailand and Cambodia, we enrolled children aged 1-12 years who were infected with HIV and had CD4 percentages of 15-24%. Participants were randomly assigned (1:1) by a minimisation scheme to start antiretroviral therapy at study entry (early treatment group) or antiretroviral therapy to start when CD4 percentages declined to less than 15% (deferred treatment group). The primary endpoint was AIDS-free survival (based on US Centers for Disease Control and Prevention category C events) at week 144, assessed with the Kaplan-Meier analysis and the log-rank approach. This study is registered with ClinicalTrials.gov, number NCT00234091. Findings Between March 28,2006, and Sept 10,2008, we enrolled 300 Thai and Cambodian children infected with HIV, with a median age of 6.4 years (IQR 3.9-8.4). 150 children were randomly allocated early antiretroviral therapy (one participant was excluded from analyses after withdrawing before week 0) and 150 children were randomly allocated deferred antiretroviral therapy. Median baseline CD4 percentage was 19% (16-22%). 69 children (46%) in the deferred treatment group started antiretroviral therapy during the study. AIDS-free survival at week 144 in the deferred treatment group was 98.7% (95% CI 94.7-99.7; 148 of 150 patients) compared with 97.9% (93.7-99.3; 146 of 149 patients) in the early treatment group (p=0.6). Interpretation AIDS-free survival in both treatment groups was high. This low event rate meant that our study was underpowered to detect differences between treatment start times and thus additional follow-up of study participants or future studies are needed to answer this clinical question. specialized THAILANDE CAMBODGE 052 050 12 12 933-941 2012 1473-3099 https://www.documentation.ird.fr/hor/fdi:010058207 10.1016/s1473-3099(12)70242-6 1473-3099 [F B010058207] https://www.documentation.ird.fr/hor/fdi:010058207 https://www.documentation.ird.fr/intranet/publi/2013/01/010058207.pdf Accès réservé (Intranet de l'IRD) IRD - Base Horizon / Pleins textes 2013-02-06 2017-08-23 fdi:010058207 fre