title: A pilot trial of adding maraviroc to suppressive antiretroviral therapy for suboptimal CD4⁺ T-cell recovery despite sustained virologic suppression: ACTG A5256.
abstract: BACKGROUND
  Despite viral suppression, antiretroviral therapy (ART) does not restore CD4(+) T-cell counts in many patients infected with human immunodeficiency virus type 1 (HIV-1).
  
  
  METHODS
  In a single-arm pilot trial involving ART recipients with suppressed plasma levels of HIV-1 RNA for at least 48 weeks and stable suboptimal CD4(+) T-cell recovery, subjects added maraviroc, a CCR5 antagonist, to their existing ART for 24 weeks. After stopping maraviroc, they were followed for an additional 24 weeks. A Wilcoxon signed-rank test was used to evaluate whether maraviroc was associated with an increase of at least 20 cells/µL in the CD4(+) T-cell count.
  
  
  RESULTS
  A total of 34 subjects were enrolled. The median age was 50 years, and the median baseline CD4(+) T-cell count was 153 cells/µL. The median increase in CD4(+) T-cell count from baseline to week 22/24 was 12 cells/µL (90% confidence interval, 1-22). A CD4(+) T-cell count increase of at least 20 cells/µL was not detected (P = .97). Markers of immune activation and apoptosis decreased during maraviroc intensification; this decline partially reversed after discontinuing maraviroc.
  
  
  CONCLUSIONS
  Adding maraviroc to suppressive ART for 24 weeks was not associated with an increase in CD4(+) T-cell counts of at least 20 cells/µL. Further studies of CCR5 antagonists in the dampening of immune activation associated with HIV infection are warranted. Clinical Trials Registration. NCT 00709111.
authors: Division of Infectious Diseases, Weill Cornell Medical College, New York, New York 10011, USA. tiw2001@med.cornell.edu
authors: Timothy J
authors: TJ
authors: Wilkin
authors: Christina M
authors: CM
authors: Lalama
authors: John
authors: J
authors: McKinnon
authors: Rajesh T
authors: RT
authors: Gandhi
authors: Nina
authors: N
authors: Lin
authors: Alan
authors: A
authors: Landay
authors: Heather
authors: H
authors: Ribaudo
authors: Lawrence
authors: L
authors: Fox
authors: Judith S
authors: JS
authors: Currier
authors: John W
authors: JW
authors: Mellors
authors: Roy
authors: R
authors: Gulick
authors: Allan R
authors: AR
authors: Tenorio
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D003510:Cyclohexanes / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D014230:Triazoles / Q000627:therapeutic use*; D019562:Viral Load; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D014230:Triazoles; D000077592:Maraviroc