title: Vicriviroc and peripheral neuropathy: results from AIDS Clinical Trials Group 5211.
abstract: OBJECTIVE
  To evaluate the effect of vicriviroc (VCV) on peripheral neuropathy (PN), the most prevalent neurological complication of HIV infection in HIV-1-infected treatment- experienced population.
  
  
  METHODS
  A5211 is a randomized placebo- controlled trial evaluating VCV in treatment-experienced HIV participants failing current therapy. Participants were randomized to VCV (5, 10, or 15 mg) or placebo with optimized ritonavir-containing antiretroviral therapy and followed for 48 weeks. PN was defined as having at least mild loss of vibration bilaterally or ankle reflexes absent or hypoactive bilaterally. We estimated the association between VCV (pooled doses) with PN using a logistic generalized estimating equation. Additional outcomes included symptomatic neuropathy (SPN), painful neuropathy (PPN), and neuropathic signs and symptoms.
  
  
  RESULTS
  118 participants (92% male, 65% white, median age of 46 years, median baseline CD4 139, median HIV-1 RNA 4.58 log) were randomized (90 on VCV and 28 on placebo). VCV therapy did not result in a statistically significant difference relative to placebo in PN (OR = 1.52; P = .39; 95% CI 0.59, 3.90) after controlling for baseline PN status and baseline neurotoxic nucleoside reverse transcriptase inhibitor(s) use.
  
  
  CONCLUSIONS
  Treatment with VCV over 48 weeks failed to result in statistically significant effect on PN in treatment-experienced participants with HIV infection relative to placebo, however potentially important effects cannot be ruled out.
authors.affiliation: Harvard School of Public Health, Boston, Massachusetts 02115, USA. tyeh@sdac.harvard.edu
authors.forename: Tzu-min
authors.initials: TM
authors.lastname: Yeh
authors.forename: Scott R
authors.initials: SR
authors.lastname: Evans
authors.forename: Roy M
authors.initials: RM
authors.lastname: Gulick
authors.forename: David B
authors.initials: DB
authors.lastname: Clifford
mesh_terms: D000293:Adolescent; D000328:Adult; D065100:CCR5 Receptor Antagonists; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1 / Q000235:genetics / Q000254:growth & development*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000517:prevention & control; D010523:Peripheral Nervous System Diseases / Q000188:drug therapy* / Q000276:immunology / Q000821:virology*; D010879:Piperazines / Q000008:administration & dosage*; D011743:Pyrimidines / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D065100:CCR5 Receptor Antagonists; D010879:Piperazines; D011743:Pyrimidines; C486781:vicriviroc
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