@article{fdi:010058207, title = {{E}arly versus deferred antiretroviral therapy for children older than 1 year infected with {HIV} ({PREDICT}) : a multicentre, randomised, open-label trial}, author = {{P}uthanakit, {T}. and {S}aphonn, {V}. and {A}nanworanich, {J}. and {K}osalaraksa, {P}. and {H}ansudewechakul, {R}. and {V}ibol, {U}. and {K}err, {S}. {J}. and {K}anjanavanit, {S}. and {N}gampiyaskul, {C}. and {W}ongsawat, {J}. and {L}uesomboon, {W}. and {N}go-{G}iang-{H}uong, {N}icole and {C}hettra, {K}. and {C}heunyam, {T}. and {S}uwarnlerk, {T}. and {U}bolyam, {S}. and {S}hearer, {W}. {T}. and {P}aul, {R}. and {M}ofenson, {L}. {M}. and {F}ox, {L}. and {L}aw, {M}. {G}. and {C}ooper, {D}. {A}. and {P}hanuphak, {P}. and {V}un, {M}. {C}. and {R}uxrungtham, {K}.}, editor = {}, language = {{ENG}}, abstract = {{B}ackground {T}he optimum time to start antiretroviral therapy for children diagnosed with {HIV} infection after 1 year of age is unknown. {W}e assessed whether antiretroviral therapy could be deferred until {CD}4 percentages declined to less than 15% without affecting {AIDS}-free survival. {M}ethods {I}n our multicentre, randomised, open-label trial at nine research sites in {T}hailand and {C}ambodia, we enrolled children aged 1-12 years who were infected with {HIV} and had {CD}4 percentages of 15-24%. {P}articipants 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 {CD}4 percentages declined to less than 15% (deferred treatment group). {T}he primary endpoint was {AIDS}-free survival (based on {US} {C}enters for {D}isease {C}ontrol and {P}revention category {C} events) at week 144, assessed with the {K}aplan-{M}eier analysis and the log-rank approach. {T}his study is registered with {C}linical{T}rials.gov, number {NCT}00234091. {F}indings {B}etween {M}arch 28,2006, and {S}ept 10,2008, we enrolled 300 {T}hai and {C}ambodian 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. {M}edian baseline {CD}4 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). {I}nterpretation {AIDS}-free survival in both treatment groups was high. {T}his 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.}, keywords = {{THAILANDE} ; {CAMBODGE}}, booktitle = {}, journal = {{L}ancet {I}nfectious {D}iseases}, volume = {12}, numero = {12}, pages = {933--941}, ISSN = {1473-3099}, year = {2012}, DOI = {10.1016/s1473-3099(12)70242-6}, URL = {https://www.documentation.ird.fr/hor/fdi:010058207}, }