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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Univax Biologics Inc
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | 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
