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

NCT ID: NCT00002248

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL

Brief 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.

Detailed 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.

Conditions

Cryptosporidiosis; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Cryptosporidium Immune Whey Protein Concentrate (Bovine)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Univax Biologics Inc

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

United States

References

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)

Reference Type: BACKGROUND

Other Identifiers

UNX-4101

Identifier Type: -

Identifier Source: secondary_id

081A

Identifier Type: -

Identifier Source: org_study_id