The purpose of this project was to determine whether amitriptyline or mexiletine were superior to placebo in providing relief from the painful symptoms of HIV-associated predominantly sensory neuropathy. Two patients enrolled into this study during this past year. Both completed the study as per protocol. One reported an improvement in neuropathy symptoms while the other reported no change. These two patients were the only active patients for this trial during this time period. We have recruited 10 patients total at Hopkins for this trial. Nationwide, 146 subjects enrolled into this study. This study was reviewed by the Performance and Safety Monitoring Board on 12/10/96. No clear treatment advantage emerged during the interim analysis in either active treatment arm (amytriptyline or mexiletine). Although both amitriptyline and mexiletine reduced pain during week eight compared to baseline, this benefit was not statistically superior to that observed among placebo subjects. Given the smaller than anticipated difference among the three treatment arms, it was unlikely that even if the study were fully enrolled (original recruitment goal was 240 subjects), there would be sufficient power to detect a statistically significant difference in clinical outcome among the arms. For this reason, early closure was recommended. The final subject visit deadline was January 10, 1997 and study closure/data to be complete by April 4, 1997. Final results are expected to be available in Spring 1997.
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