PLoS ONE (Jan 2013)

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

  • 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

DOI
https://doi.org/10.1371/journal.pone.0080157
Journal volume & issue
Vol. 8, no. 11
p. e80157

Abstract

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BackgroundImmunological 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.MethodsWe designed a multi-centric, randomized, parallel, open label, phase 4 superiority trial. We enrolled 97 patients on HAART with CD4+ResultsBy 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.ConclusionsMaraviroc 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.Trial registrationClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858.