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dc.contributor.authorBeatriz Grinsztejnen_US
dc.contributor.authorMina C. Hosseinipouren_US
dc.contributor.authorHeather J. Ribaudoen_US
dc.contributor.authorSusan Swindellsen_US
dc.contributor.authorJoseph Eronen_US
dc.contributor.authorYing Q. Chenen_US
dc.contributor.authorLei Wangen_US
dc.contributor.authorSan San Ouen_US
dc.contributor.authorMaija Andersonen_US
dc.contributor.authorMarybeth McCauleyen_US
dc.contributor.authorTheresa Gambleen_US
dc.contributor.authorNagalingeshwaran Kumarasamyen_US
dc.contributor.authorJames G. Hakimen_US
dc.contributor.authorJohnstone Kumwendaen_US
dc.contributor.authorJose H.S. Pilottoen_US
dc.contributor.authorSheela V. Godboleen_US
dc.contributor.authorSuwat Chariyalertsaken_US
dc.contributor.authorMarineide Gonçalves De Meloen_US
dc.contributor.authorKenneth H. Mayeren_US
dc.contributor.authorSusan H. Eshlemanen_US
dc.contributor.authorEstelle Piwowar-Manningen_US
dc.contributor.authorJoseph Makhemaen_US
dc.contributor.authorLisa A. Millsen_US
dc.contributor.authorRavindre Panchiaen_US
dc.contributor.authorIan Sanneen_US
dc.contributor.authorJoel Gallanten_US
dc.contributor.authorIrving Hoffmanen_US
dc.contributor.authorTaha E. Tahaen_US
dc.contributor.authorKarin Nielsen-Sainesen_US
dc.contributor.authorDavid Celentanoen_US
dc.contributor.authorMax Essexen_US
dc.contributor.authorDiane Havliren_US
dc.contributor.authorMyron S. Cohenen_US
dc.description.abstractBackground: Use of antiretroviral treatment for HIV-1 infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-1. However, the best time to initiate antiretroviral treatment to reduce progression of HIV-1 infection or non-AIDS clinical events is unknown. We reported previously that early antiretroviral treatment reduced HIV-1 transmission by 96%. We aimed to compare the effects of early and delayed initiation of antiretroviral treatment on clinical outcomes. Methods: The HPTN 052 trial is a randomised controlled trial done at 13 sites in nine countries. We enrolled HIV-1-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation, stratified by site. Random assignment was unblinded. The HIV-1-infected member of every couple initiated antiretroviral treatment either on entry into the study (early treatment group) or after a decline in CD4 count or with onset of an AIDS-related illness (delayed treatment group). Primary events were AIDS clinical events (WHO stage 4 HIV-1 disease, tuberculosis, and severe bacterial infections) and the following serious medical conditions unrelated to AIDS: serious cardiovascular or vascular disease, serious liver disease, end-stage renal disease, new-onset diabetes mellitus, and non-AIDS malignant disease. Analysis was by intention-to-treat. This trial is registered with, number NCT00074581. Findings: 1763 people with HIV-1 infection and a serodiscordant partner were enrolled in the study; 886 were assigned early antiretroviral treatment and 877 to the delayed treatment group (two individuals were excluded from this group after randomisation). Median CD4 counts at randomisation were 442 (IQR 373-522) cells per μL in patients assigned to the early treatment group and 428 (357-522) cells per μL in those allocated delayed antiretroviral treatment. In the delayed group, antiretroviral treatment was initiated at a median CD4 count of 230 (IQR 197-249) cells per μL. Primary clinical events were reported in 57 individuals assigned to early treatment initiation versus 77 people allocated to delayed antiretroviral treatment (hazard ratio 0·73, 95% CI 0·52-1·03; p=0·074). New-onset AIDS events were recorded in 40 participants assigned to early antiretroviral treatment versus 61 allocated delayed initiation (0·64, 0·43-0·96; p=0·031), tuberculosis developed in 17 versus 34 patients, respectively (0·49, 0·28-0·89, p=0·018), and primary non-AIDS events were rare (12 in the early group vs nine with delayed treatment). In total, 498 primary and secondary outcomes occurred in the early treatment group (incidence 24·9 per 100 person-years, 95% CI 22·5-27·5) versus 585 in the delayed treatment group (29·2 per 100 person-years, 26·5-32·1; p=0·025). 26 people died, 11 who were allocated to early antiretroviral treatment and 15 who were assigned to the delayed treatment group. Interpretation: Early initiation of antiretroviral treatment delayed the time to AIDS events and decreased the incidence of primary and secondary outcomes. The clinical benefits recorded, combined with the striking reduction in HIV-1 transmission risk previously reported, provides strong support for earlier initiation of antiretroviral treatment. Funding: US National Institute of Allergy and Infectious Diseases. © 2014 Elsevier Ltd.en_US
dc.titleEffects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: Results from the phase 3 HPTN 052 randomised controlled trialen_US
article.title.sourcetitleThe Lancet Infectious Diseasesen_US
article.volume14en_US Hutchinson Cancer Research Centeren_US Hopkins Bloomberg School of Public Healthen_US Mai Universityen_US of North Carolina School of Medicineen_US Johns Hopkins School of Medicineen_US School of Public Healthen_US 360en_US AIDS Research Institute Indiaen_US Nossa Senhora da Conceicaoen_US Oswaldo Cruzen_US of Zimbabween_US of California, San Franciscoen_US of North Carolina Project Malawien_US R Gaitonade Center for AIDS Research and Educationen_US of Malawi College of Medicineen_US Harvard AIDS Institute Partnershipen_US Instituteen_US 360en_US Geffen School of Medicine at UCLAen_US of Witwatersranden_US of Nebraska Medical Centeren_US
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