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
Completed · Phase 1
Conditions studied: Cryptosporidiosis, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002248
- Run by
- Univax Biologics Inc
- People needed
- 40
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Gabin Med Group — Los Angeles, California, United States
- UCSF - San Francisco Gen Hosp — San Francisco, California, United States
- AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
- New England Med Ctr — Boston, Massachusetts, United States
- Saint Elizabeth's Hosp — Boston, Massachusetts, United States
- Cornell Univ Med Ctr — New York, New York, United States
Full record on ClinicalTrials.gov
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