GMHC Treatment Issues, Volume 10, Number 1 - January 1996
Theo Smart

Unimed Pharmaceuticals has announced FDA approval of a compassionate use program providing very limited access to nitazoxanide (NTZ), an anti-crypto- sporidial agent currently in clinical trials (see Treatment Issues, September, 1995, page 14). The company is also opening a site in San Francisco at the Kaiser HIV Research Group (investigator: W.J. Fessel, M.D.) to speed the ongoing American phase II studies of the drug. Meanwhile, the Mexican licensee of the drug has initiated phase III clinical trials in that country for people with AIDS-related cryptosporidiosis. Data from this study should contribute to the eventual application for FDA approval of NTZ.

The compassionate use protocol is currently limited to 30 patients until the FDA is provided with additional safety data, but the size is expected to increase over time. Its purpose is to provide access to people with cryptosporidiosis who do not qualify for or cannot enroll in the ongoing study which excludes those who have other concurrent gastrointestinal infections such as microsporidiosis. Doctors wishing to enroll their patients in this protocol can call 800/864-6330. Twenty patients had already enrolled in this program as of early January.

AmBisome for Mycoses

An ongoing double blind study of AmBisome, the Fujisawa USA's liposome-encapsulated version of amphotericin B, is now open to people with relapsing cryptococcal meningitis (CM) that remains sensitive to fluconazole (which is used as maintenance therapy).

Previously, participation in the study had been restricted to people with primary CM. The study compares AmBisome to standard amphotericin treatment and currently has 50 patients enrolled. For information on trial sites, call the government's national clearinghouse at 800/TRIALS-A. Liposomal versions of amphotericin are thought to be considerably safer than the unprocessed product (see Treatment Issues, April, 1994, pages 6, 9-12) A number of open-label studies have reported positive responses with AmBisome in people with CM who have failed amphotericin treatment.

Fujisawa also has opened a general compassionate use program to provide AmBisome to anyone with systemic fungal infections who is intolerant to amphotericin or for whom amphotericin would be contraindicated. The protocol is also open to patients with candidiasis resistant to the triazole antifungal medications such as fluconazole. (Maintenance therapy to prevent recurrence may require once or twice weekly infusions of AmBisome.) For more information, call Fujisawa's Medical Information Line at 800/727-7003.

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