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

Official Title: “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.

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.

Intervention(s) in this Clinical Trial

• Drug: Cryptosporidium Immune Whey Protein Concentrate (Bovine)

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Univax Biologics Inc Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002248

Study ID Number: 081A

ClinicalTrials.gov Identifier: NCT00002248

Health Authority: United States: Food and Drug Administration