Thalidomide for Aphthous Ulcers in HIV Infection

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Abstract
Jacobson et al. (May 22 issue)1 report encouraging results in their placebo-controlled trial of thalidomide for aphthous ulceration in patients with human immunodeficiency virus (HIV) infection. However, potential enthusiasm must be muted because of the preliminary nature of the findings and the unanticipated safety issues raised by the results. The data are based on an interim analysis of only 57 patients. Even in this small sample, major adverse events were seen during the four-week treatment phase, including grade 4 neutropenia in two thalidomide recipients. Approximately half the study participants either discontinued the study medication or had a protocol-mandated reduction in the dose during the four-week study period. This raises questions about the tolerability of thalidomide at a dose of 200 mg in this patient population for this indication.