drugset / Trial / NCT00002248

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

NCT00002248 ↗

Phase 1 Completed 40 enrolled Univax Biologics Inc
Double-blindTreatment

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.

Timeline

Start
—
Primary completion
—
Completion
—

Publications

  • Background Nord J, Ma P, Tacket CO, Dijohn D, Tzipori S, Sahner D, Shieb G. Treatment of AIDS associated cryptosporidiosis with hyperimmune colostrum from cows vaccinated with cryptosporidium. Int Conf AIDS. 1989 Jun 4-9;5:656 (abstract no C586)

Drugs

EvaluationDrugModalityDoseRoute
Subject bovine anti-Cryptosporidium immunoglobulin Protein / enzyme biologic — —