Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002248
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief 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 Enteritis in AIDS Patients
Sponsor:
Univax Biologics Inc
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
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 Enteritis in AIDS Patients
Status:
COMPLETED
Status Verified Date:
1993-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
SECONDARY To assess changes in stool consistency and frequency body weight and safety in this patient population
Detailed Description:
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNX-4101 | None | None | None |