| Title: |
Maraviroc as Intensification Strategy in HIV-1 Positive Patients with Deficient Immunological Response: an Italian Randomized Clinical Trial |
| Authors: |
S. Rusconi; P. Vitiello; E. Colella; A. Capetti; F. Bai; M. Morosi; P. Tau; E. Merlini; G. Marchetti; F. Adorni; E. Focà; P. Meraviglia; C. Abeli; S. Bonora; M. D'Annunzio; A. Di Biagio; M. Di Pietro; L. Butini; G. Orofino; M. Colafigli; G. d'Ettorre; D. Francisci; G. Parruti; A. Soria; A. R. Buonomini; C. Tommasi; S. Mosti; S. Di Nardo Stuppino; M. Montano |
| Contributors: |
S. Rusconi; P. Vitiello; F. Adorni; E. Colella; E. Focà; A. Capetti; P. Meraviglia; C. Abeli; S. Bonora; M. D'Annunzio; A. Di Biagio; M. Di Pietro; L. Butini; G. Orofino; M. Colafigli; G. D'Ettorre; D. Francisci; G. Parruti; A. Soria; A.R. Buonomini; C. Tommasi; S. Mosti; F. Bai; S. Di Nardo Stuppino; M. Morosi; M. Montano; P. Tau; E. Merlini; G. Marchetti |
| Publisher Information: |
Public Library of Science |
| Publication Year: |
2013 |
| Collection: |
The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| Subject Terms: |
Settore MED/17 - Malattie Infettive |
| Description: |
BACKGROUND: 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. METHODS: We designed a multi-centric, randomized, parallel, open label, phase 4 superiority trial. We enrolled 97 patients on HAART with 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. CONCLUSIONS: 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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/24244635; info:eu-repo/semantics/altIdentifier/wos/WOS:000327143800129; volume:8; issue:11; firstpage:e80157; journal:PLOS ONE; https://hdl.handle.net/2434/228716 |
| DOI: |
10.1371/journal.pone.0080157 |
| Availability: |
https://hdl.handle.net/2434/228716; https://doi.org/10.1371/journal.pone.0080157 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.1239FD09 |
| Database: |
BASE |