Table of Contents
Volume 2013 (2013), Article ID 358294, 10 pages
Research Article

Improvements in Immune Function and Activation with 48-Week Darunavir/Ritonavir-Based Therapy: GRACE Substudy

1Department of Microbiology and Immunology, McGill University Health Centre, Room A5-140, 1650 Cedar Avenue, Montreal, QC, Canada H3G 1A4
2Montreal General Hospital, Flowcytometry Laboratory, 1650 Cedar Avenue, Room C10-166, Montreal, QC, Canada H3G 1A4
3LAC+USC Medical Center, 1200 N State Street, Room IPT-C4E100, Los Angeles, CA 90033, USA
4Janssen Services, LLC, Clinical Affairs, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA

Received 12 August 2013; Accepted 17 November 2013

Academic Editors: G. D'ettorre and C. Petrovas

Copyright © 2013 Christos Tsoukas et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Objective. During the course of HIV infection, progressive immune deficiency occurs. The aim of this prospective substudy was to evaluate the recovery of functional immunity in a subset of patients from the GRACE (Gender, Race, And Clinical Experience) study treated with a DRV/r-based regimen. Methods. The recovery of functional immunity with a darunavir/ritonavir-based regimen was assessed in a subset of treatment-experienced, HIV-1 infected patients from the GRACE study. Results. 19/32 patients (59%) enrolled in the substudy were virologically suppressed (<50 copies/mL). In these patients, median (range) CD4+ cell count increased from 222 (2, 398) cells/mm3 at baseline to 398 (119, 812) cells/mm3 at Week 48. CD8+% decreased significantly from baseline to Week 48 ( ). Proliferation of CD4+ lymphocytes in response to CD3+/CD28+, phytohemagglutinin, and pokeweed was significantly increased ( ) by Week 12. Proliferation in response to Candida and tetanus was significantly increased by Week 48 ( and , resp.). Staphylococcal enterotoxin B-stimulated tumor necrosis factor-alpha and interleukin-2 in CD4+ cells was significantly increased by Week 12 ( ) and Week 48 ( ), respectively. Conclusions. Darunavir/ritonavir-based therapy demonstrated improvements in CD4+ cell recovery and association with progressive functional immune recovery over 48 weeks. This trial is registered with NCT00381303.