Journal Article

Thalidomide as Therapy for Human Immunodeficiency Virus—Related Oral Ulcers: A Double-Blind Placebo-Controlled Clinical Trial

Velia A. Ramirez-Amador, Lilly Esquivel-Pedraza, Sergio Ponce-de-Leon, Gustavo Reyes-Teran, Martha Gonzalez-Guevara, Samuel Ponce-de-Leon and Juan G. Sierra-Madero

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 28, issue 4, pages 892-894
Published in print April 1999 | ISSN: 1058-4838
Published online April 1999 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/515222
Thalidomide as Therapy for Human Immunodeficiency Virus—Related Oral Ulcers: A Double-Blind Placebo-Controlled Clinical Trial

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A double-blind, randomized, placebo-controlled clinical trial was performed in Mexico City to evaluate the efficacy of thalidomide in treating oral recurrent aphthae in human immunodeficiency virus (HIV)-infected subjects. Sixteen HIV-infected patients with clinical and histological diagnosis of oral recurrent aphthous ulcerations received randomly an 8-week course of either thalidomide or placebo, with an initial oral dosage of 400 mg/d for 1 week, followed by 200 mg/d for 7 weeks. Ten subjects received thalidomide and six received placebo. At 8 weeks, nine subjects (90%) in the thalidomide group had complete healing of their ulcers, compared with two (33.3%) of the six patients in the placebo group (P = .03). There was a significant reduction in largest ulcer diameter in the thalidomide group. Rash was observed in 80% of the thalidomide patients. Although thalidomide demonstrated an unquestionable benefit in treatment of oral ulcers in HIV patients, caution must be taken given the frequent occurrence of side effects.

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Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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