• Taylor Harrison, Sachiko Miyahara, Anthony Lee, Scott Evans, Barbara Bastow, David Simpson, Ian Gilron, Robert Dworkin, Eric S Daar, Linda Wieclaw, David B Clifford, and ACTG A5252 Team.
• Department of Neurology, Emory University School of Medicine, Grady Memorial Hospital, Atlanta, Georgia 30303, USA. tharri4@emory.edu
• Pain Med. 2013 Jul 1; 14 (7): 103910471039-47.

ObjectiveThere is limited evidence for efficacy of analgesics as monotherapy for neuropathic pain associated with HIV-associated polyneuropathies, in spite of demonstrated efficacy in other neuropathic pain conditions. We evaluated the tolerability and analgesic efficacy of duloxetine, methadone, and the combination of duloxetine-methadone compared with placebo.DesignThis study was a phase II, randomized, double-blind, placebo-controlled, four-period crossover multicenter study of analgesic therapy for patients with at least moderate neuropathic pain due to HIV-associated polyneuropathy. Duloxetine, methadone, combination duloxetine-methadone, and placebo were administered in four different possible sequences. The primary outcome measure was mean pain intensity (MPI) measured daily in a study-supplied pain diary.ResultsA total of 15 patients were enrolled from eight study sites and eight patients completed the entire trial. Study treatments failed to show statistically significant change in MPI compared with placebo. Adverse events were frequent and associated with high rates of drug discontinuation and study dropout.ConclusionsChallenges with participant recruitment and poor retention precluded trial completion to its planned targets, limiting our evaluation of the analgesic efficacy of the study treatments. Challenges to successful completion of this study and lessons learned are discussed.Wiley Periodicals, Inc.

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