Journal Article

Itraconazole Prophylaxis for Fungal Infections in Patients with Advanced Human Immunodeficiency Virus Infection: Randomized, Placebo-Controlled, Double-Blind Study

David S. McKinsey, L. Joseph Wheat, Gretchen A. Cloud, Mark Pierce, John R. Black, David M. Bamberger, Mitchell Goldman, Carolynn J. Thomas, Heidi M. Gutsch, Bruce Moskovitz, William E. Dismukes and Carol A. Kauffman

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 28, issue 5, pages 1049-1056
Published in print May 1999 | ISSN: 1058-4838
Published online May 1999 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/514744
Itraconazole Prophylaxis for Fungal Infections in Patients with Advanced Human Immunodeficiency Virus Infection: Randomized, Placebo-Controlled, Double-Blind Study

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In a prospective, randomized, double-blind trial, 149 patients with advanced human immunodeficiency virus (HIV) infection were randomized to receive itraconazole capsules (200 mg daily) and 146 to receive a matched placebo. Both groups were monitored for evidence of fungal infections. Baseline characteristics of the two groups were similar. Failure of prophylaxis occurred in 29 (19%) of the itraconazole recipients and 42 (29%) of the placebo recipients (P = .004; log-rank test). There were 6 invasive fungal infections in the itraconazole group (4, histoplasmosis; 1, cryptococcosis; 1, aspergillosis) and 19 in the placebo group (10, histoplasmosis; 8, cryptococcosis; 1, aspergillosis) (P = .0007; log-rank test). Itraconazole significantly delayed time to onset of histoplasmosis (P = .03; log-rank test) and cryptococcosis (P = .0005; log-rank test). Prophylaxis failure due to recurrent or refractory mucosal candidiasis occurred with similar frequency in the two groups (itraconazole, 15%; placebo, 16%). A survival benefit was not demonstrated. Itraconazole generally was well tolerated. Primary prophylaxis with itraconazole capsules prevents histoplasmosis and cryptococcosis in patients with HIV infection.

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

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