A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy… (NCT00002248) | Clinical Trial Compass
CompletedPhase 1
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
United States40 participants
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, pa…