Abstract

This Project will evaluate the effectiveness of amitriptyline and mexilitene in relieving pain symptoms in patients with HIV-related painful neuropathy. The study is a three arm parallel group, placebo controlled clinical trial, with subjects randomly assigned to receive on of three treatments: amitriptyline, mexilitene or placebo. The does will be titrated upward during the initial 4 weeks of the trial, then maintained for the second four weeks of study. Benztropine will be used as an """"""""active placebo"""""""". Response parameters will include a standardized neurological exam, a global assessment of pain response, and the requirement for additional analgesic agents. Serum levels of study drugs will be determined. It is calculated that 80 patients per arm (240 subjects total) will be required.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS032228-07
Application #
6445212
Study Section
Project Start
2001-05-01
Project End
2002-12-31
Budget Start
Budget End
Support Year
7
Fiscal Year
2001
Total Cost
$140,288
Indirect Cost

  Institution

Name
Washington University
Department
Type
DUNS #
062761671
City
Saint Louis
State
MO
Country
United States
Zip Code
63130

  Publications

Lee, Anthony J; Bosch, Ronald J; Evans, Scott R et al. (2015) Patterns of peripheral neuropathy in ART-naïve patients initiating modern ART regimen. J Neurovirol 21:210-8
Sacktor, Ned; Miyahara, Sachiko; Evans, Scott et al. (2014) Impact of minocycline on cerebrospinal fluid markers of oxidative stress, neuronal injury, and inflammation in HIV-seropositive individuals with cognitive impairment. J Neurovirol 20:620-6
Longbrake, Erin E; Ances, Beau M; Viets, Ryan B et al. (2013) Susac syndrome in a patient with human immunodeficiency virus infection. J Neurovirol 19:270-3
Zhang, Xinyan; Tierney, Camlin; Albrecht, Mary et al. (2013) Discordant associations between SLCO1B1 521T?C and plasma levels of ritonavir-boosted protease inhibitors in AIDS clinical trials group study A5146. Ther Drug Monit 35:209-16
Chen, Huichao; Clifford, David B; Deng, Lijuan et al. (2013) Peripheral neuropathy in ART-experienced patients: prevalence and risk factors. J Neurovirol 19:557-64
Nakasujja, Noeline; Miyahara, Sachiko; Evans, Scott et al. (2013) Randomized trial of minocycline in the treatment of HIV-associated cognitive impairment. Neurology 80:196-202
Harrison, Taylor; Miyahara, Sachiko; Lee, Anthony et al. (2013) Experience and challenges presented by a multicenter crossover study of combination analgesic therapy for the treatment of painful HIV-associated polyneuropathies. Pain Med 14:1039-47
Nguyen, Anh; Rossi, Steven; Croteau, David et al. (2013) Etravirine in CSF is highly protein bound. J Antimicrob Chemother 68:1161-8
Evans, Scott R; Lee, Anthony J; Ellis, Ronald J et al. (2012) HIV peripheral neuropathy progression: protection with glucose-lowering drugs? J Neurovirol 18:428-33
Phan-Ba, Rémy; Lommers, Emilie; Tshibanda, Luaba et al. (2012) MRI preclinical detection and asymptomatic course of a progressive multifocal leucoencephalopathy (PML) under natalizumab therapy. J Neurol Neurosurg Psychiatry 83:224-6

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