Trials / Completed
CompletedNCT00002248
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- Univax Biologics Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cryptosporidium Immune Whey Protein Concentrate (Bovine) |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002248. Inclusion in this directory is not an endorsement.