To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and on the relationship between microsporidial counts in stool and stool frequency and volume. To correlate microsporidial counts with the clinical course of microsporidiosis.
In the double-blind portion of study, patients receive albendazole or placebo for 28 days; in the open-label portion of study, patients receive albendazole for 62 days.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
San Francisco Gen Hosp / Div of GI
San Francisco, California, United States
Davies Med Ctr
San Francisco, California, United States
George Washington Univ 5-403A
Washington D.C., District of Columbia, United States
Deaconess Hosp / Harvard Med School / Infect Disease
Boston, Massachusetts, United States
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New York Univ
New York, New York, United States
Saint Luke's Hosp / Services and Research 1301
New York, New York, United States