Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.

Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.

<h4>Background</h4>Immunological non-responders (INRs) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression. We assessed immune reconstitution profile upon intensification with maraviroc in INRs.<h4>Methods</h4>We desig...

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Autores principales: Stefano Rusconi, Paola Vitiello, Fulvio Adorni, Elisa Colella, Emanuele Focà, Amedeo Capetti, Paola Meraviglia, Clara Abeli, Stefano Bonora, Marco D'Annunzio, Antonio Di Biagio, Massimo Di Pietro, Luca Butini, Giancarlo Orofino, Manuela Colafigli, Gabriella d'Ettorre, Daniela Francisci, Giustino Parruti, Alessandro Soria, Anna Rita Buonomini, Chiara Tommasi, Silvia Mosti, Francesca Bai, Silvia Di Nardo Stuppino, Manuela Morosi, Marco Montano, Pamela Tau, Esther Merlini, Giulia Marchetti
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Publicado: Public Library of Science (PLoS) 2013
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spelling oai:doaj.org-article:fde61c47e2224ac98aa3fcc74da664262021-11-18T08:46:26ZMaraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.1932-620310.1371/journal.pone.0080157https://doaj.org/article/fde61c47e2224ac98aa3fcc74da664262013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24244635/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>Immunological non-responders (INRs) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression. We assessed immune reconstitution profile upon intensification with maraviroc in INRs.<h4>Methods</h4>We designed a multi-centric, randomized, parallel, open label, phase 4 superiority trial. We enrolled 97 patients on HAART with CD4+<200/µL and/or CD4+ recovery ≤ 25% and HIV-RNA<50 cp/mL. Patients were randomized 1:1 to HAART+maraviroc or continued HAART. CD4+ and CD8+ CD45+RA/RO, Ki67 expression and plasma IL-7 were quantified at W0, W12 and W48.<h4>Results</h4>By W48 both groups displayed a CD4 increase without a significant inter-group difference. A statistically significant change in CD8 favored patients in arm HAART+maraviroc versus HAART at W12 (p=.009) and W48 (p=.025). The CD4>200/µL and CD4>200/µL + CD4 gain ≥ 25% end-points were not satisfied at W12 (p=.24 and p=.619) nor at W48 (p=.076 and p=.236). Patients continuing HAART displayed no major changes in parameters of T-cell homeostasis and activation. Maraviroc-receiving patients experienced a significant rise in circulating IL-7 by W48 (p=.01), and a trend in temporary reduction in activated HLA-DR+CD38+CD4+ by W12 (p=.06) that was not maintained at W48.<h4>Conclusions</h4>Maraviroc intensification in INRs did not have a significant advantage in reconstituting CD4 T-cell pool, but did substantially expand CD8. It resulted in a low rate of treatment discontinuations.<h4>Trial registration</h4>ClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858.Stefano RusconiPaola VitielloFulvio AdorniElisa ColellaEmanuele FocàAmedeo CapettiPaola MeravigliaClara AbeliStefano BonoraMarco D'AnnunzioAntonio Di BiagioMassimo Di PietroLuca ButiniGiancarlo OrofinoManuela ColafigliGabriella d'EttorreDaniela FrancisciGiustino ParrutiAlessandro SoriaAnna Rita BuonominiChiara TommasiSilvia MostiFrancesca BaiSilvia Di Nardo StuppinoManuela MorosiMarco MontanoPamela TauEsther MerliniGiulia MarchettiPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 11, p e80157 (2013)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Stefano Rusconi
Paola Vitiello
Fulvio Adorni
Elisa Colella
Emanuele Focà
Amedeo Capetti
Paola Meraviglia
Clara Abeli
Stefano Bonora
Marco D'Annunzio
Antonio Di Biagio
Massimo Di Pietro
Luca Butini
Giancarlo Orofino
Manuela Colafigli
Gabriella d'Ettorre
Daniela Francisci
Giustino Parruti
Alessandro Soria
Anna Rita Buonomini
Chiara Tommasi
Silvia Mosti
Francesca Bai
Silvia Di Nardo Stuppino
Manuela Morosi
Marco Montano
Pamela Tau
Esther Merlini
Giulia Marchetti
Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.
description <h4>Background</h4>Immunological non-responders (INRs) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression. We assessed immune reconstitution profile upon intensification with maraviroc in INRs.<h4>Methods</h4>We designed a multi-centric, randomized, parallel, open label, phase 4 superiority trial. We enrolled 97 patients on HAART with CD4+<200/µL and/or CD4+ recovery ≤ 25% and HIV-RNA<50 cp/mL. Patients were randomized 1:1 to HAART+maraviroc or continued HAART. CD4+ and CD8+ CD45+RA/RO, Ki67 expression and plasma IL-7 were quantified at W0, W12 and W48.<h4>Results</h4>By W48 both groups displayed a CD4 increase without a significant inter-group difference. A statistically significant change in CD8 favored patients in arm HAART+maraviroc versus HAART at W12 (p=.009) and W48 (p=.025). The CD4>200/µL and CD4>200/µL + CD4 gain ≥ 25% end-points were not satisfied at W12 (p=.24 and p=.619) nor at W48 (p=.076 and p=.236). Patients continuing HAART displayed no major changes in parameters of T-cell homeostasis and activation. Maraviroc-receiving patients experienced a significant rise in circulating IL-7 by W48 (p=.01), and a trend in temporary reduction in activated HLA-DR+CD38+CD4+ by W12 (p=.06) that was not maintained at W48.<h4>Conclusions</h4>Maraviroc intensification in INRs did not have a significant advantage in reconstituting CD4 T-cell pool, but did substantially expand CD8. It resulted in a low rate of treatment discontinuations.<h4>Trial registration</h4>ClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858.
format article
author Stefano Rusconi
Paola Vitiello
Fulvio Adorni
Elisa Colella
Emanuele Focà
Amedeo Capetti
Paola Meraviglia
Clara Abeli
Stefano Bonora
Marco D'Annunzio
Antonio Di Biagio
Massimo Di Pietro
Luca Butini
Giancarlo Orofino
Manuela Colafigli
Gabriella d'Ettorre
Daniela Francisci
Giustino Parruti
Alessandro Soria
Anna Rita Buonomini
Chiara Tommasi
Silvia Mosti
Francesca Bai
Silvia Di Nardo Stuppino
Manuela Morosi
Marco Montano
Pamela Tau
Esther Merlini
Giulia Marchetti
author_facet Stefano Rusconi
Paola Vitiello
Fulvio Adorni
Elisa Colella
Emanuele Focà
Amedeo Capetti
Paola Meraviglia
Clara Abeli
Stefano Bonora
Marco D'Annunzio
Antonio Di Biagio
Massimo Di Pietro
Luca Butini
Giancarlo Orofino
Manuela Colafigli
Gabriella d'Ettorre
Daniela Francisci
Giustino Parruti
Alessandro Soria
Anna Rita Buonomini
Chiara Tommasi
Silvia Mosti
Francesca Bai
Silvia Di Nardo Stuppino
Manuela Morosi
Marco Montano
Pamela Tau
Esther Merlini
Giulia Marchetti
author_sort Stefano Rusconi
title Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.
title_short Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.
title_full Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.
title_fullStr Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.
title_full_unstemmed Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.
title_sort maraviroc as intensification strategy in hiv-1 positive patients with deficient immunological response: an italian randomized clinical trial.
publisher Public Library of Science (PLoS)
publishDate 2013
url https://doaj.org/article/fde61c47e2224ac98aa3fcc74da66426
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