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From the University of Rochester Medical Center (Dr. Kieburtz), Rochester, NY; Mt. Sinai Medical Center (Dr. Simpson), New York, NY; the Center for Biostatistics in AIDS Research (Dr. Yiannoutsos), Boston, MA; the National Institute of Dental Research (Dr. Max), Bethesda, MD; University of North Carolina (Dr. Hall), Chapel Hill, NC; University of California (Dr. Ellis), San Diego, CA; University of Washington (Dr. Marra), Seattle, WA; University of Texas Medical Branch (Dr. McKendall), Galveston, TX; UCLA ACTG & UCLA CARE Center (Dr. Singer), Los Angeles, CA; Johns Hopkins University School of Medicine (Dr. Dal Pan), Baltimore, MD; Washington University School of Medicine (Dr. Clifford), St. Louis, MO; Case Western Reserve University (Dr. Tucker), Cleveland, OH; and Northwestern University/Chicago AIDS Clinical Trials Unit (Dr. Cohen), Chicago, IL.
Address correspondence and reprint requests to Dr. Karl Kieburtz, University of Rochester Medical Center, 1351 Mt. Hope Avenue, Suite 220, Rochester, NY 14620.
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.
Supported in part by the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases and by the Neurologic AIDS Research Consortium of the National Institute of Neurologic Disorders and Stroke (NS 32228), and by the General Clinical Research Center Units (RR00044, RR00772, RR00865, RR00046, RR00071) of the National Center for Research Resources. Mexiletine and matching placebo were provided by Boerhinger-Ingelheim, Ridgefield, CT.
Presented in part at the 122nd annual meeting of the American Neurological Association; September 30, 1997; San Diego, CA.
Received June 24, 1998. Accepted in final form August 22, 1998.
*See the Appendix on page 1687 for a list of members of the AIDS Clinical Trial Group 242 Protocol Team.
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