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Maraviroc as Intensification Strategy in HIV-1 Positive Patients with Deficient Immunological Response: an Italian Randomized Clinical Trial

2013; Public Library of Science; Volume: 8; Issue: 11 Linguagem: Inglês

10.1371/journal.pone.0080157

1932-6203

Stefano Rusconi, Paola Vitiello, Fulvio Adorni, Elisa Colella, Emanuele Focà, Amedeo Capetti, Paola Meraviglia, C 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 Aurélio Echart Montano, Pamela Tau, Esther Merlini, Giulia Marchetti,

Mosquito-borne diseases and control

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.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 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.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.ClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858.