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Randomized, Double-blind, Placebo-Controlled study of 100-mg Oral Fluconazole Daily

David A. Stevens, MD; S. Ira Greene, MD; Onnie S. Lang, RN

Arch Intern Med. 1991;151(12):2458-2464.

Abstract
Recurrent oropharyngeal candidiasis is common in patients with acquired immunodeficiency syndrome and the acquired immunodeficiency syndrome—related complex. It causes local pain and discomfort, loss of taste, and aversion to food and may lead to secondary complications. We examined, in a double-blind study, whether recurrent thrush could be prevented by prophylaxis. Twenty-five patients with one to four previous thrush episodes who had no thrush at the outset of the study were randomized to receive 100 mg of fluconazole or placebo daily for 12 weeks. If thrush occurred, prophylaxis was stopped and patients were treated conventionally, after which prophylaxis was resumed. After the randomized study, some patients were given continuous fluconazole (open phase). In the randomized study, thrush occurred in eight of 13 placebo-treated patients and none of 12 fluconazole-treated patients. possible side effects were not different between the groups. Dermatophytosis and onychomycosis and cryptococcuria also improved in the fluconazole-treated patients, and fungal colonization was significantly decreased. One episode of thrush occurred in the open phase in an intermittently compliant patient (group total, 71.5 patient-months of fluconazole treatment); in contrast, the 25 patients also had had two episodes of Candida esophagitis, three of cryptococcosis, and 13 of dermatophytosis before entry. Subsequent to entry in the randomized trial, in 92.3 patientmonths without fluconazole, there were 35 episodes of thrush, one of esophagitis, one of cryptococcemia, and one of dermatophytosis, and preexisting dermatophytosis and onychomycosis were unchanged or worsened. Individual patients observed with and without fluconazole treatment also showed its efficacy. In conclusion, thrush can be prevented in patients with acquired immunodeficiency syndrome and the acquired immunodeficiency syndrome— related complex with negligible toxic effects. Larger trials to confirm prevention of all mycoses with prophylaxis should be considered.

(Arch Intern Med. 1991;151:2458-2464)

Author Affiliations
From the AIDS Program (Drs Stevens and Greene and Ms Lang) and Divisions of Infectious Diseases (Dr Stevens) and Dermatology (Dr Greene), Department of Medicine, Santa Clara Valley Medical Center, San Jose, Calif; California Institute for Medical Research, San Jose (Dr Stevens); and Stanford (Calif) University Medical School (Drs Stevens and Greene).

Footnotes
Accepted for publication May 29, 1991.

Presented in part at the Sixth International Conference on AIDS, San Francisco, Calif, June 1990.

Reprint requests to Division of Infectious Diseases, Department of Medicine, Santa Clara Valley Medical Center, 751 S Bascom Ave, San Jose, CA 95128 (Dr Stevens).

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