Vicriviroc and peripheral neuropathy: results from AIDS Clinical Trials Group 5211.

TitleVicriviroc and peripheral neuropathy: results from AIDS Clinical Trials Group 5211.
Publication TypeJournal Article
Year of Publication2010
AuthorsYeh T-min, Evans SR, Gulick RM, Clifford DB
JournalHIV Clin Trials
Volume11
Issue1
Pagination51-8
Date Published2010 Jan-Feb
ISSN1528-4336
KeywordsAdolescent, Adult, CCR5 Receptor Antagonists, Double-Blind Method, Female, HIV Infections, HIV-1, Humans, Male, Middle Aged, Pain, Peripheral Nervous System Diseases, Piperazines, Pyrimidines, Young Adult
Abstract

PURPOSE: 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.

METHOD: 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.

CONCLUSION: 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.

DOI10.1310/hct1101-51
Alternate JournalHIV Clin Trials
PubMed ID20400411
PubMed Central IDPMC2958041
Grant ListAI-25859 / AI / NIAID NIH HHS / United States
AI-27661 / AI / NIAID NIH HHS / United States
AI-32782 / AI / NIAID NIH HHS / United States
AI-32783 / AI / NIAID NIH HHS / United States
AI-34853 / AI / NIAID NIH HHS / United States
AI-46370 / AI / NIAID NIH HHS / United States
AI-46381 / AI / NIAID NIH HHS / United States
AI-68634 / AI / NIAID NIH HHS / United States
AI-68636 / AI / NIAID NIH HHS / United States
AI-69411 / AI / NIAID NIH HHS / United States
AI-69418 / AI / NIAID NIH HHS / United States
AI-69419 / AI / NIAID NIH HHS / United States
AI-69423 / AI / NIAID NIH HHS / United States
AI-69424 / AI / NIAID NIH HHS / United States
AI-69432 / AI / NIAID NIH HHS / United States
AI-69434 / AI / NIAID NIH HHS / United States
AI-69439 / AI / NIAID NIH HHS / United States
AI-69450 / AI / NIAID NIH HHS / United States
AI-69465 / AI / NIAID NIH HHS / United States
AI-69471 / AI / NIAID NIH HHS / United States
AI-69472 / AI / NIAID NIH HHS / United States
AI-69474 / AI / NIAID NIH HHS / United States
AI-69494 / AI / NIAID NIH HHS / United States
AI-69495 / AI / NIAID NIH HHS / United States
AI-69501 / AI / NIAID NIH HHS / United States
AI-69502 / AI / NIAID NIH HHS / United States
AI-69532 / AI / NIAID NIH HHS / United States
AI-69556 / AI / NIAID NIH HHS / United States
K24 AI051966 / AI / NIAID NIH HHS / United States
K24-AI-51966 / AI / NIAID NIH HHS / United States
M01-RR00044 / RR / NCRR NIH HHS / United States
M01-RR00046 / RR / NCRR NIH HHS / United States
M01-RR00047 / RR / NCRR NIH HHS / United States
M01-RR00051 / RR / NCRR NIH HHS / United States
M01-RR00052 / RR / NCRR NIH HHS / United States
M01-RR00096 / RR / NCRR NIH HHS / United States
NS32228 / NS / NINDS NIH HHS / United States
P30-AI-45008 / AI / NIAID NIH HHS / United States
P30-AI-50410 / AI / NIAID NIH HHS / United States
U01 AI069495 / AI / NIAID NIH HHS / United States
U01 AI069495-01 / AI / NIAID NIH HHS / United States
U01 NS032228 / NS / NINDS NIH HHS / United States
U01 NS032228-12 / NS / NINDS NIH HHS / United States