Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers

Jeffrey M. Jacobson, John S. Greenspan, John Spritzler, Lawrence Fox, John L. Fahey, J. Brooks Jackson, Miriam Chernoff, David A. Wohl, Joseph J. Pulvirenti, Thomas M. Hooton, Cecilia Shikuma, D. Greenspan, F. Aweeka, D. Simpson, A. Wu, N. Ketter, C. Trapnell, L. Purdue, J. McFarland, W. LevyG. Jones, A. Bardequez, R. Clark, N. Quesada, P. J. Andrulis, M. W. Drulak, K. Luykx, C. Van der Horst, S. Forstat, H. Kessler, B. A. Royer, D. Ogata-Arakaki, J. S. Currier, V. T. Clemente, G. J. Vasquez, M. Cruz-Ortiz, R. Delapenha, Y. Butler, L. J. Wheat, B. W. Zwickl, R. Soiero, D. Stein, N. Basgoz, J. Doweiko, V. McAuliffe, J. Dowling, R. Hewitt, D. Blair, S. Canmann, E. Connick, S. P. Raffanti

Research output: Contribution to journalArticlepeer-review

35 Scopus citations


A multicenter, double-blind, randomized, placebo-controlled study was conducted to determine the safety and efficacy of thalidomide in reduced, intermittent doses for preventing recurrences of oral and esophageal aphthous ulcers in patients with human immunodeficiency virus (HIV) infection. Forty-nine HIV-infected patients whose ulcers previously had healed as a result of thalidomide therapy were randomly assigned to receive either 100 mg of oral thalidomide or placebo 3 times per week for 6 months. Ulcers recurred in 14 (61%) of 23 thalidomide-randomized patients, compared with 11 (42%) of 26 placebo-randomized patients, with no significant difference in the median time to recurrence of ulcers (P = .221). There were no changes in plasma levels of HIV RNA, tumor necrosis factor (TNF)-α, and soluble TNF receptor II at the time of ulcer recurrence. Adverse events among patients treated with thalidomide included neutropenia (5 patients), rash (5 patients), and peripheral sensory neuropathy (3 patients). Thalidomide in lower intermittent doses is ineffective at preventing recurrence of aphthous ulcers in HIV-infected persons.

Original languageEnglish (US)
Pages (from-to)343-346
Number of pages4
JournalJournal of Infectious Diseases
Issue number2
StatePublished - Jan 15 2001
Externally publishedYes

ASJC Scopus subject areas

  • General Medicine


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