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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002248
• Other study ID #: 081A
• Secondary ID: UNX-4101
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryptosporidiosis
• HIV Infections

Intervention

Drug:
• Cryptosporidium Immune Whey Protein Concentrate (Bovine)

Locations

Country	Name	City	State
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	Gabin Med Group	Los Angeles	California
United States	Cornell Univ Med Ctr	New York	New York
United States	UCSF - San Francisco Gen Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Univax Biologics Inc

Country where clinical trial is conducted

United States, 

References & 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)