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Clinical Trial
. 1998 Dec;51(6):1682-8.
doi: 10.1212/wnl.51.6.1682.

A randomized trial of amitriptyline and mexiletine for painful neuropathy in HIV infection. AIDS Clinical Trial Group 242 Protocol Team

K Kieburtz  1 , D Simpson, C Yiannoutsos, M B Max, C D Hall, R J Ellis, C M Marra, R McKendall, E Singer, G J Dal Pan, D B Clifford, T Tucker, B Cohen
Affiliations
Clinical Trial

A randomized trial of amitriptyline and mexiletine for painful neuropathy in HIV infection. AIDS Clinical Trial Group 242 Protocol Team

K Kieburtz et al. Neurology. 1998 Dec.

Abstract

Background: Painful sensory neuropathy is a common complication of HIV infection. Based on prior uncontrolled observations, we hypothesized that amitriptyline or mexiletine would improve the pain symptoms.

Method: A randomized, double-blind, 10-week trial of 145 patients assigned equally to amitriptyline, mexiletine, or matching placebo. The primary outcome measure was the change in pain intensity between baseline and the final visit.

Results: The improvement in amitriptyline group (0.31+/-0.31 units [mean+/-SD]) and mexiletine group (0.23+/-0.41) was not significantly different from placebo (0.20+/-0.30). Both interventions were generally well tolerated.

Conclusions: Neither amitriptyline nor mexiletine provide significant pain relief in patients with HIV-associated painful sensory neuropathy.

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