PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis. SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.
Forty patients are randomized to receive either BACI or placebo (bovine colostrum from non-immunized cattle) for 1 week. The double-blind portion of the study will be followed by an open-label phase in which all 40 patients receive BACI for 1 week.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Gabin Med Group
Los Angeles, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
New England Med Ctr
Boston, Massachusetts, United States
Saint Elizabeth's Hosp
Boston, Massachusetts, United States
Cornell Univ Med Ctr
New York, New York, United States
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