Expanded access and expanded trials
Smart, T.
Gmhc Treatment Issues the Gay Men's Health Crisis Newsletter of Experimental Aids Therapies 10(1): 8
1996
ISSN/ISBN: 1077-1824 PMID: 11363376 Document Number: 459265
The Food and Drug Administration (FDA) approved a compassionate use program for Unimed Pharmaceutical's nitazoxanide. The compassionate use protocol is currently limited to 30 patients until additional safety data are obtained, at which time it will be expanded. Its purpose is to provide access to people with cryptosporidiosis who do not qualify for or cannot enroll in other ongoing studies. AmBisome, Fujisawa USA's liposome-encapsulated version of amphotericin B, is available to people with relapsing cryptococcal meningitis who still remain sensitive to fluconazole. Fujisawa also 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.