- ICH GCP
- US Clinical Trials Registry
- Clinical 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90067
- Gabin Med Group
-
San Francisco, California, United States, 94110
- UCSF - San Francisco Gen Hosp
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- AIDS Research Consortium of Atlanta
-
-
Massachusetts
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Boston, Massachusetts, United States, 02111
- New England Med Ctr
-
Boston, Massachusetts, United States, 02135
- Saint Elizabeth's Hosp
-
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New York
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New York, New York, United States, 10021
- Cornell Univ Med Ctr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antidiarrheal compounds (if dose remains stable).
- Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry).
Patients must have:
- AIDS.
- Cryptosporidium parvum enteritis.
- Chronic diarrhea.
- Life expectancy of at least 4 weeks.
- Ability to tolerate food by mouth.
- Ability to take the histamine H2-receptor antagonist famotidine (Pepcid).
Prior Medication:
Allowed:
- Antidiarrheal compounds (provided dose has remained stable in the 7 days prior to study entry).
- Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose has remained stable for at least 4 weeks prior to study entry).
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening.
- Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis.
- Grossly bloody diarrhea.
- Known allergy to milk or milk products (other than lactose intolerance).
Prior Medication:
Excluded:
- Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: DOUBLE
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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)
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 081A
- UNX-4101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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