Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: A randomized clinical trial
dc.contributor.author | Martinez, Esteban | |
dc.contributor.author | Gonzalez-Cordon, Ana | |
dc.contributor.author | Ferrer, Elena | |
dc.contributor.author | Domingo, Pere | |
dc.contributor.author | Negredo, Eugenia | |
dc.contributor.author | Gutierrez, Felix | |
dc.contributor.author | Portilla, Joaquin | |
dc.contributor.author | Curran, Adrià | |
dc.contributor.author | Podzamczer, Daniel | |
dc.contributor.author | Ribera, Esteban | |
dc.contributor.author | Murillas, Javier | |
dc.contributor.author | Bernardino, Jose I. | |
dc.contributor.author | Santos Gil, Ignacio de los | |
dc.contributor.author | Carton, Jose A. | |
dc.contributor.author | Peraire, Joaquim | |
dc.contributor.author | Pich, Judit | |
dc.contributor.author | Deulofeu, Ramon | |
dc.contributor.author | Pérez, Ignacio | |
dc.contributor.author | Gatell, Jose M. | |
dc.contributor.author | Arnaiz, Juan A. | |
dc.contributor.author | Beleta, Helena | |
dc.contributor.author | Garcia, David | |
dc.contributor.author | Pejenaute, Andrea | |
dc.contributor.author | Ramos, Nuria | |
dc.contributor.author | Arcaina, P. | |
dc.contributor.author | Giner, L. | |
dc.contributor.author | Moya, S. | |
dc.contributor.author | Pampliega, M. | |
dc.contributor.author | Portilla, J. | |
dc.contributor.author | Barrera, G. | |
dc.contributor.author | Podzamczer, Daniel | |
dc.contributor.author | Rozas, N. | |
dc.contributor.author | Saumoy, M. | |
dc.contributor.author | Ferrer, E. | |
dc.contributor.author | Asensi, V. | |
dc.contributor.author | Cartón, J. A. | |
dc.contributor.author | Gatell, J. M. | |
dc.contributor.author | González-Cordón, A. | |
dc.contributor.author | Pérez, I. | |
dc.contributor.author | Martínez, E. | |
dc.contributor.author | Masiá, M. | |
dc.contributor.author | Padilla, S. | |
dc.contributor.author | Ramos, J. R. | |
dc.contributor.author | Robledano, C. | |
dc.contributor.author | Gutiérrez, F. | |
dc.contributor.author | Puig, J. | |
dc.contributor.author | Negredo, E. | |
dc.contributor.author | Arribas López, José Ramón | |
dc.contributor.author | Castro, J. M. | |
dc.contributor.author | Bernardino, J. I. | |
dc.contributor.author | Sanz, J. | |
dc.contributor.author | Santos, I. | |
dc.contributor.author | Cairó, M. | |
dc.contributor.author | Velli, P. | |
dc.contributor.author | Dalmau, D. | |
dc.contributor.author | Lamas, A. | |
dc.contributor.author | Martí-Belda, P. | |
dc.contributor.author | Dronda, F. | |
dc.contributor.author | Blanco, J. R. | |
dc.contributor.author | Gutierrez, M. | |
dc.contributor.author | Mateo, M. G. | |
dc.contributor.author | Domingo, P. | |
dc.contributor.author | Losada, E. | |
dc.contributor.author | Prieto, A. | |
dc.contributor.author | Antela, A. | |
dc.contributor.author | Murillas, J. | |
dc.contributor.author | Aguilar, A. | |
dc.contributor.author | Peraire, J. | |
dc.contributor.author | Vargas, M. | |
dc.contributor.author | Viladés, C. | |
dc.contributor.author | Vidal, F. | |
dc.contributor.author | Crespo, M. | |
dc.contributor.author | Curran, A. | |
dc.contributor.author | Ribera, Esteban | |
dc.contributor.author | Arnaiz, J. A. | |
dc.contributor.author | Beleta, H. | |
dc.contributor.author | Garcia, D. | |
dc.contributor.author | Pejenaute, Andrea | |
dc.contributor.author | Ramos, Nuria | |
dc.contributor.author | Pich, J. | |
dc.contributor.other | UAM. Departamento de Medicina | es_ES |
dc.date.accessioned | 2016-06-21T14:19:33Z | |
dc.date.available | 2016-06-21T14:19:33Z | |
dc.date.issued | 2015-01-01 | |
dc.identifier.citation | Clinical Infectious Diseases 60.5 (2015): 811-820 | en_US |
dc.identifier.issn | 1058-4838 (print) | es_ES |
dc.identifier.issn | 1537-6591 (on line) | es_ES |
dc.identifier.uri | http://hdl.handle.net/10486/671589 | |
dc.description | This article has been accepted for publication in Clinical Infectious Diseases ©2014 The Authors .Published by Oxford University Press on Clinical Infectious Disease 60.5. DOI: 10.1093/cid/ciu898 | en_US |
dc.description.abstract | Background. It is unclear whether metabolic or body composition effects may differ between protease inhibitor-based regimens recommended for initial treatment of HIV infection. Methods. ATADAR is a phase IV, open-label, multicenter randomized clinical trial. Stable antiretroviral-naive HIV-infected adults were randomly assigned to atazanavir/ritonavir 300/100 mg or darunavir/ritonavir 800/100 mg in combination with tenofovir/emtricitabine daily. Pre-defined end-points were treatment or virological failure, drug discontinuation due to adverse effects, and laboratory and body composition changes at 96 weeks. Results. At 96 weeks, 56 (62%) atazanavir/ritonavir and 62 (71%) darunavir/ritonavir patients remained free of treatment failure (estimated difference 8.2%; 95%CI -0.6 to 21.6); and 71 (79%) atazanavir/ritonavir and 75 (85%) darunavir/ritonavir patients remained free of virological failure (estimated difference 6.3%; 95%CI -0.5 to 17.6). Seven vs. five patients discontinued atazanavir/ritonavir or darunavir/ritonavir due to adverse effects. Total and HDL cholesterol similarly increased in both arms, but triglycerides increased more in atazanavir/ritonavir arm. At 96 weeks, body fat (estimated difference 2862.2 gr; 95%CI 726.7 to 4997.7; P=0.0090), limb fat (estimated difference 1403.3 gr; 95%CI 388.4 to 2418.2; P=0.0071), and subcutaneous abdominal adipose tissue (estimated difference 28.4 cm2; 95%CI 1.9 to 55.0; P=0.0362) increased more in atazanavir/ritonavir than in darunavir/ritonavir arm. Body fat changes in atazanavir/ritonavir arm were associated with higher insulin resistance. Conclusions. We found no major differences between atazanavir/ritonavir and darunavir/ritonavir in efficacy, clinically-relevant side effects, or plasma cholesterol fractions. However, atazanavir/ritonavir led to higher triglycerides and total and subcutaneous fat than darunavir/ritonavir and fat gains with atazanavir/ritonavir were associated with insulin resistance | en_US |
dc.description.sponsorship | This is an Investigator Sponsored Research study. It was supported in part by research grants from Bristol‐Myers Squibb and Janssen‐Cilag; Instituto de Salud Carlos III (PI12/01217) and Red Temática Cooperativa de Investigación en SIDA G03/173 (RIS‐EST11), Ministerio de Ciencia e Innovación, Spain. (Registration number: NCT01274780; registry name: ATADAR; EUDRACT; 2010‐021002‐38). | en_US |
dc.format.extent | 33 pag. | es_ES |
dc.format.mimetype | application/pdf | en |
dc.language.iso | eng | en |
dc.publisher | Oxford University Press | en_US |
dc.relation.ispartof | Clinical Infectious Diseases | en_US |
dc.rights | © The Author 2014 | en_US |
dc.subject.other | Antiretroviral therapy | en_US |
dc.title | Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: A randomized clinical trial | en_US |
dc.type | article | en |
dc.subject.eciencia | Medicina | es_ES |
dc.relation.publisherversion | http://dx.doi.org/10.1093/cid/ciu898 | es_ES |
dc.identifier.doi | 10.1093/cid/ciu898 | es_ES |
dc.identifier.publicationfirstpage | 811 | es_ES |
dc.identifier.publicationissue | 5 | es_ES |
dc.identifier.publicationlastpage | 820 | es_ES |
dc.identifier.publicationvolume | 60 | es_ES |
dc.relation.projectID | Gobierno de España. NCT01274780 | es_ES |
dc.type.version | info:eu-repo/semantics/acceptedVersion | en_US |
dc.rights.accessRights | openAccess | en |
dc.facultadUAM | Facultad de Medicina |