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dc.contributor.authorJudith S. Currieren_US
dc.contributor.authorPaula Brittoen_US
dc.contributor.authorRisa M. Hoffmanen_US
dc.contributor.authorSean Brummelen_US
dc.contributor.authorGaerolwe Mashetoen_US
dc.contributor.authorEsau Joaoen_US
dc.contributor.authorBreno Santosen_US
dc.contributor.authorLinda Aurpibulen_US
dc.contributor.authorMarcelo Lossoen_US
dc.contributor.authorMarie F. Pierreen_US
dc.contributor.authorAdriana Weinbergen_US
dc.contributor.authorDevasena Gnanashanmugamen_US
dc.contributor.authorNahida Chakhtouraen_US
dc.contributor.authorKarin Klingmanen_US
dc.contributor.authorRenee Browningen_US
dc.contributor.authorAnne Colettien_US
dc.contributor.authorLynne Mofensonen_US
dc.contributor.authorDavid Shapiroen_US
dc.contributor.authorJose Pilottoen_US
dc.contributor.authorManuela Bulloen_US
dc.contributor.authorSilvina Ivaloen_US
dc.contributor.authorAnthony Ogwuen_US
dc.contributor.authorTebogo Kakhuen_US
dc.contributor.authorAida Asmelashen_US
dc.contributor.authorAyotunde Omoz-Oarheen_US
dc.contributor.authorCristina Hoferen_US
dc.contributor.authorElizabeth MacHadoen_US
dc.contributor.authorJacqueline Menezesen_US
dc.contributor.authorLeon Claude Sidien_US
dc.contributor.authorJorge Pintoen_US
dc.contributor.authorFlavia Ferreiraen_US
dc.contributor.authorGeraldo Duarteen_US
dc.contributor.authorConrado Milani Coutinhoen_US
dc.contributor.authorRosa Dea Sperhackeen_US
dc.contributor.authorSilvia Mariani Costamilanen_US
dc.contributor.authorLuis Eduardo Fernandesen_US
dc.contributor.authorLuiz Felipe Mpreiraen_US
dc.contributor.authorRegis Kreitchmannen_US
dc.contributor.authorDebora Fernandes Coelhoen_US
dc.contributor.authorMarineide Goncalves De Meloen_US
dc.contributor.authorRita De Cassia Alves Liraen_US
dc.contributor.authorLinda Aristhomeneen_US
dc.contributor.authorJerry Bonhommeen_US
dc.contributor.authorRosa Infanteen_US
dc.contributor.authorFanny Rosasen_US
dc.contributor.authorEsmelda Montalbanen_US
dc.contributor.authorJessica Riosen_US
dc.contributor.authorJulkanya Chokephaibulkiten_US
dc.contributor.authorThanomsak Anekthananonen_US
dc.contributor.authorJullapong Achalapongen_US
dc.contributor.authorPacharee Kantipongen_US
dc.contributor.authorGuttiga Halueen_US
dc.contributor.authorWirawan Rasrien_US
dc.contributor.authorPrapap Yuthavisuthien_US
dc.contributor.authorMalee Techapornroongen_US
dc.contributor.authorSinart Prommasen_US
dc.contributor.authorPrapaisri Layangoolen_US
dc.contributor.authorChureeratana Bowonwatanuwongen_US
dc.contributor.authorNantasak Chotivanichen_US
dc.contributor.authorFuanglada Tongpraserten_US
dc.contributor.authorPatcharaphan Sugandhavesaen_US
dc.contributor.authorVanessa Cajahuaringaen_US
dc.contributor.authorRenee Weinmanen_US
dc.contributor.authorSara Mattiuccien_US
dc.contributor.authorPrincy Kumaren_US
dc.contributor.authorJoseph Timponeen_US
dc.contributor.authorChivon McMullen-Jacksonen_US
dc.contributor.authorShelley Buschuren_US
dc.description.abstractBackground Health benefits of postpartum antiretroviral therapy (ART) for human immunodeficiency virus (HIV) positive women with high CD4+ T-counts have not been assessed in randomized trials. Methods Asymptomatic, HIV-positive, non-breastfeeding women with pre-ART CD4+ T-cell counts ≥ 400 cells/mm3started on ART during pregnancy were randomized up to 42 days after delivery to continue or discontinue ART. Lopinavir/ritonavir plus tenofovir/emtricitabine was the preferred ART regimen. The sample size was selected to provide 88% power to detect a 50% reduction from an annualized primary event rate of 2.07%. A post-hoc analysis evaluated HIV/AIDS-related and World Health Organization (WHO) Stage 2 and 3 events. All analyses were intent to treat. Results 1652 women from 52 sites in Argentina, Botswana, Brazil, China, Haiti, Peru, Thailand and the US were enrolled (1/2010-11/2014). Median age was 28 years and major racial categories were Black African (28%), Asian (25%) White (15%). Median entry CD4 count was 696 cells/mm3(IQR 575±869), median ART exposure prior to delivery was 19 weeks (IQR 13± 24) and 94% had entry HIV-1 RNA < 1000 copies/ml. After a median follow-up of 2.3 years, the primary composite endpoint rate was significantly lower than expected, and not significantly different between arms (continue arm 0.21 /100 person years(py); discontinue 0.31/ 100 py, Hazard ratio (HR) 0.68, 95% CI: 0.19, 2.40). WHO Stage 2 and 3 events were significantly reduced with continued ART (2.08/100 py vs. 4.36/100 py in the discontinue arm; HR 0.48, 95%CI: 0.33, 0.70). Toxicity rates did not differ significantly between arms. Among women randomized to continue ART, 189/827 (23%) had virologic failure; of the 155 with resistance testing, 103 (66%) failed without resistance to their current regimen, suggesting non-adherence. Conclusions Overall, serious clinical events were rare among young HIV-positive post-partum women with high CD4 cell counts. Continued ART was safe and was associated with a halving of the rate of WHO 2/3 conditions. Virologic failure rates were high, underscoring the urgent need to improve adherence in this population. Trial registration NCT00955968.en_US
dc.subjectAgricultural and Biological Sciencesen_US
dc.subjectBiochemistry, Genetics and Molecular Biologyen_US
dc.titleRandomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells/mm<sup>3</sup>en_US
article.title.sourcetitlePLoS ONEen_US
article.volume12en_US Geffen School of Medicine at UCLAen_US for Biostatistics in AIDS Researchen_US Harvard AIDS Partnershipen_US Federal dos Servidores do Estadoen_US Conceicaoen_US Mai Universityen_US J.M. Ramos Meijaen_US of Colorado Health Sciences Centeren_US Institute of Allergy and Infectious Diseasesen_US Facilitation Departmenten_US Glaser Pediatric AIDS Foundationen_US Oswaldo Cruzen_US
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