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
2 other identifiers
interventional
40
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1993
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Gabin Med Group
Los Angeles, California, 90067, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Saint Elizabeth's Hosp
Boston, Massachusetts, 02135, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1993-04