Clinical Trial: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium

Brief Summary:

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.

Detailed Summary: 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.
Sponsor: Univax Biologics Inc

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: NIH AIDS Clinical Trials Information Service

Dates:
Date Received: November 2, 1999
Date Started:
Date Completion:
Last Updated: June 23, 2005
Last Verified: April 1993