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

J. M. Jacobson, J. S. Greenspan, J. Spritzler, L. Fox, J. L. Fahey, J. B. Jackson, M. Chernoff, D. A. Wohl, J. J. Pulvirenti, Thomas Hooton, C. 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, Jr Andrulis P.J., 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 journalArticle

31 Citations (Scopus)

Abstract

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
Pages (from-to)343-346
Number of pages4
JournalJournal of Infectious Diseases
Volume183
Issue number2
DOIs
StatePublished - Jan 15 2001
Externally publishedYes

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Aphthous Stomatitis
Thalidomide
HIV
Recurrence
Ulcer
Placebos
Tumor Necrosis Factor Receptors
Peripheral Nervous System Diseases
Virus Diseases
Exanthema
Neutropenia
Tumor Necrosis Factor-alpha
RNA
Safety

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

Cite this

Jacobson, J. M., Greenspan, J. S., Spritzler, J., Fox, L., Fahey, J. L., Jackson, J. B., ... Raffanti, S. P. (2001). Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers. Journal of Infectious Diseases, 183(2), 343-346. https://doi.org/10.1086/317928

Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers. / Jacobson, J. M.; Greenspan, J. S.; Spritzler, J.; Fox, L.; Fahey, J. L.; Jackson, J. B.; Chernoff, M.; Wohl, D. A.; Pulvirenti, J. J.; Hooton, Thomas; Shikuma, C.; Greenspan, D.; Aweeka, F.; Simpson, D.; Wu, A.; Ketter, N.; Trapnell, C.; Purdue, L.; McFarland, J.; Levy, W.; Jones, G.; Bardequez, A.; Clark, R.; Quesada, N.; Andrulis P.J., Jr; Drulak, M. W.; Luykx, K.; Van der Horst, C.; Forstat, S.; Kessler, H.; Royer, B. A.; Ogata-Arakaki, D.; Currier, J. S.; Clemente, V. T.; Vasquez, G. J.; Cruz-Ortiz, M.; Delapenha, R.; Butler, Y.; Wheat, L. J.; Zwickl, B. W.; Soiero, R.; Stein, D.; Basgoz, N.; Doweiko, J.; McAuliffe, V.; Dowling, J.; Hewitt, R.; Blair, D.; Canmann, S.; Connick, E.; Raffanti, S. P.

In: Journal of Infectious Diseases, Vol. 183, No. 2, 15.01.2001, p. 343-346.

Research output: Contribution to journalArticle

Jacobson, JM, Greenspan, JS, Spritzler, J, Fox, L, Fahey, JL, Jackson, JB, Chernoff, M, Wohl, DA, Pulvirenti, JJ, Hooton, T, Shikuma, C, Greenspan, D, Aweeka, F, Simpson, D, Wu, A, Ketter, N, Trapnell, C, Purdue, L, McFarland, J, Levy, W, Jones, G, Bardequez, A, Clark, R, Quesada, N, Andrulis P.J., J, Drulak, MW, Luykx, K, Van der Horst, C, Forstat, S, Kessler, H, Royer, BA, Ogata-Arakaki, D, Currier, JS, Clemente, VT, Vasquez, GJ, Cruz-Ortiz, M, Delapenha, R, Butler, Y, Wheat, LJ, Zwickl, BW, Soiero, R, Stein, D, Basgoz, N, Doweiko, J, McAuliffe, V, Dowling, J, Hewitt, R, Blair, D, Canmann, S, Connick, E & Raffanti, SP 2001, 'Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers', Journal of Infectious Diseases, vol. 183, no. 2, pp. 343-346. https://doi.org/10.1086/317928
Jacobson, J. M. ; Greenspan, J. S. ; Spritzler, J. ; Fox, L. ; Fahey, J. L. ; Jackson, J. B. ; Chernoff, M. ; Wohl, D. A. ; Pulvirenti, J. J. ; Hooton, Thomas ; Shikuma, C. ; Greenspan, D. ; Aweeka, F. ; Simpson, D. ; Wu, A. ; Ketter, N. ; Trapnell, C. ; Purdue, L. ; McFarland, J. ; Levy, W. ; Jones, G. ; Bardequez, A. ; Clark, R. ; Quesada, N. ; Andrulis P.J., Jr ; Drulak, M. W. ; Luykx, K. ; Van der Horst, C. ; Forstat, S. ; Kessler, H. ; Royer, B. A. ; Ogata-Arakaki, D. ; Currier, J. S. ; Clemente, V. T. ; Vasquez, G. J. ; Cruz-Ortiz, M. ; Delapenha, R. ; Butler, Y. ; Wheat, L. J. ; Zwickl, B. W. ; Soiero, R. ; Stein, D. ; Basgoz, N. ; Doweiko, J. ; McAuliffe, V. ; Dowling, J. ; Hewitt, R. ; Blair, D. ; Canmann, S. ; Connick, E. ; Raffanti, S. P. / Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers. In: Journal of Infectious Diseases. 2001 ; Vol. 183, No. 2. pp. 343-346.
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abstract = "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.",
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AU - Jacobson, J. M.

AU - Greenspan, J. S.

AU - Spritzler, J.

AU - Fox, L.

AU - Fahey, J. L.

AU - Jackson, J. B.

AU - Chernoff, M.

AU - Wohl, D. A.

AU - Pulvirenti, J. J.

AU - Hooton, Thomas

AU - Shikuma, C.

AU - Greenspan, D.

AU - Aweeka, F.

AU - Simpson, D.

AU - Wu, A.

AU - Ketter, N.

AU - Trapnell, C.

AU - Purdue, L.

AU - McFarland, J.

AU - Levy, W.

AU - Jones, G.

AU - Bardequez, A.

AU - Clark, R.

AU - Quesada, N.

AU - Andrulis P.J., Jr

AU - Drulak, M. W.

AU - Luykx, K.

AU - Van der Horst, C.

AU - Forstat, S.

AU - Kessler, H.

AU - Royer, B. A.

AU - Ogata-Arakaki, D.

AU - Currier, J. S.

AU - Clemente, V. T.

AU - Vasquez, G. J.

AU - Cruz-Ortiz, M.

AU - Delapenha, R.

AU - Butler, Y.

AU - Wheat, L. J.

AU - Zwickl, B. W.

AU - Soiero, R.

AU - Stein, D.

AU - Basgoz, N.

AU - Doweiko, J.

AU - McAuliffe, V.

AU - Dowling, J.

AU - Hewitt, R.

AU - Blair, D.

AU - Canmann, S.

AU - Connick, E.

AU - Raffanti, S. P.

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N2 - 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.

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