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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002248
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1993

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002248 on ClinicalTrials.gov Archive Site
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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
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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Cryptosporidiosis
  • HIV Infections
Drug: Cryptosporidium Immune Whey Protein Concentrate (Bovine)
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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, paromomycin) within 30 days prior to study entry.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002248
081A, UNX-4101
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Univax Biologics Inc
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NIH AIDS Clinical Trials Information Service
April 1993

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP