Clinical Trials

MainTitle

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
Univax Biologics Inc


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002248

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1993
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Cryptosporidiosis
HIV Infections

Drug : Cryptosporidium Immune Whey Protein Concentrate (Bovine)
Phase 1

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Enrollment: 40

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002248

Locations

United States, California
Gabin Med Group
Los Angeles, California, United States, 90067
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
Saint Elizabeth's Hosp
Boston, Massachusetts, United States, 02135
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021

Sponsors and Collaborators

Univax Biologics Inc
More Information

More Information


Responsible Party: Univax Biologics Inc  
ClinicalTrials.gov Identifier: NCT00002248   History of Changes  
Other Study ID Numbers: 081A  
  UNX-4101  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Antidiarrheals
Cryptosporidiosis
Diarrhea
Acquired Immunodeficiency Syndrome
Cryptosporidium
Immunization, Passive

Additional relevant MeSH terms:
Cryptosporidiosis
Enteritis

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.