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Fluconazole Compared with Amphotericin B plus Flucytosine for Cryptococcal Meningitis in AIDS: A Randomized Trial

Robert A. Larsen, MD; Mary Ann E. Leal, MD; and Linda S. Chan, PhD
[+] Article, Author, and Disclosure Information

Grant Support: In part by Pfizer Central Research Inc., Groton, CT 06340.

Requests for Reprints: Robert A. Larsen, MD, Infectious Diseases, Pediatric Pavilion, Room 2E10, 1129 North State Street, Los Angeles, CA 90033.

Current Author Addresses: Drs. Larsen and Leal: Infectious Diseases, Pediatric Pavilion, Room 2E10, 1129 North State Street, Los Angeles, CA 90033.

Dr. Chan: Department of Biostatistics, Room 12-900, Los Angeles County-University of Southern California Medical Center, 1200 North State Street, Los Angeles, CA 90033.

© 1990 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1990;113(3):183-187. doi:10.7326/0003-4819-113-3-183
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Objective: To compare the efficacy of fluconazole with amphotericin B plus flucytosine in the treatment of cryptococcal meningitis.

Design: Patients were randomly assigned to oral fluconazole, 400 mg/d, ,for 10 weeks or to amphotericin B, 0.7 mg/kg body weight daily for 1 week, then three times weekly for 9 weeks combined with flucytosine, 150 mg/kg d, in four divided doses.

Setting: Los Angeles County-University of Southern California Medical Center.

Patients: Between 15 February and 7 December 1988, 42 patients had evidence of their first episode of cryptococcal meningitis, of whom 21 participated in the trial. All patients enrolled were men with the acquired immunodeficiency syndrome (AIDS) except one woman who was receiving prednisone therapy and was excluded from the final analysis.

Results: Of 14 patients with AIDS assigned to fluconazole, 8 (57%; 95% CI, 29% to 82%) failed; none of the 6 patients with AIDS failed who were assigned to amphotericin B plus flucytosine therapy (0%; CI, 0% to 46%) (Fisher exact test, P = 0.04). The mean duration of positive cerebrospinal fluid cultures was 40.6 ± 5.4 days in patients receiving fluconazole and 15.6 ± 6.6 days in patients receiving amphotericin B plus flucytosine (Mann-Whitney test, P = 0.02). Overall, 4 patients assigned to fluconazole therapy died whereas no patient assigned to amphotericin B plus flucytosine therapy died (Fisher exact test, P = 0.27).

Conclusion: Amphotericin B used in combination with flucytosine has superior mycologie and clinical efficacy compared with fluconazole for the treatment of cryptococcal meningitis in patients with AIDS.





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