The immunologic effects of maraviroc intensification in treated HIV-infected individuals with incomplete CD4+ T-cell recovery: a randomized trial

Blood. 2013 Jun 6;121(23):4635-46. doi: 10.1182/blood-2012-06-436345. Epub 2013 Apr 15.

Abstract

The CCR5 inhibitor maraviroc has been hypothesized to decrease T-cell activation in HIV-infected individuals, but its independent immunologic effects have not been established in a placebo-controlled trial. We randomized 45 HIV-infected subjects with CD4 counts <350 cells per mm(3) and plasma HIV RNA levels <48 copies per mL on antiretroviral therapy (ART) to add maraviroc vs placebo to their regimen for 24 weeks followed by 12 weeks on ART alone. Compared with placebo-treated subjects, maraviroc-treated subjects unexpectedly experienced a greater median increase in % CD38+HLA-DR+ peripheral blood CD8+ T cells at week 24 (+2.2% vs -0.7%, P = .014), and less of a decline in activated CD4+ T cells (P < .001). The % CD38+HLA-DR+ CD4+ and CD8+ T cells increased nearly twofold in rectal tissue (both P < .001), and plasma CC chemokine receptor type 5 (CCR5) ligand (macrophage-inflammatory protein 1β) levels increased 2.4-fold during maraviroc intensification (P < .001). During maraviroc intensification, plasma lipopolysaccharide declined, whereas sCD14 levels and neutrophils tended to increase in blood and rectal tissue. Although the mechanisms explaining these findings remain unclear, CCR5 ligand-mediated activation of T cells, macrophages, and neutrophils via alternative chemokine receptors should be explored. These results may have relevance for trials of maraviroc for HIV preexposure prophylaxis and graft-versus-host disease. This trial was registered at www.clinicaltrials.gov as #NCT00735072.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • CCR5 Receptor Antagonists
  • CD4-Positive T-Lymphocytes / drug effects
  • CD4-Positive T-Lymphocytes / immunology*
  • CD4-Positive T-Lymphocytes / virology
  • Cyclohexanes / therapeutic use*
  • Female
  • Gastrointestinal Tract / drug effects
  • Gastrointestinal Tract / immunology
  • Gastrointestinal Tract / virology
  • Graft vs Host Disease / drug therapy
  • Graft vs Host Disease / immunology*
  • Graft vs Host Disease / virology
  • HIV Fusion Inhibitors / therapeutic use
  • HIV Infections / drug therapy
  • HIV Infections / immunology*
  • HIV Infections / virology
  • HIV-1 / drug effects
  • HIV-1 / immunology*
  • Humans
  • Immunophenotyping
  • Lymphocyte Activation / drug effects
  • Lymphoid Tissue / drug effects
  • Lymphoid Tissue / immunology
  • Lymphoid Tissue / virology
  • Male
  • Maraviroc
  • Middle Aged
  • RNA, Viral / blood
  • RNA, Viral / genetics
  • Rectum / immunology
  • Rectum / pathology
  • Rectum / surgery
  • Triazoles / therapeutic use*
  • Viral Load / drug effects*

Substances

  • CCR5 Receptor Antagonists
  • Cyclohexanes
  • HIV Fusion Inhibitors
  • RNA, Viral
  • Triazoles
  • Maraviroc

Associated data

  • ClinicalTrials.gov/NCT00735072