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
Univax Biologics Inc
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1993
History of Changes
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
SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.
Drug : Cryptosporidium Immune Whey Protein Concentrate (Bovine)
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:
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
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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).
- 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).
- 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).
- Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days
Patients must have:
Patients with the following symptoms or conditions are excluded:
Contacts and LocationsChoosing 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 Show More
|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 CollaboratorsUnivax Biologics Inc
|Responsible Party:||Univax Biologics Inc|
|ClinicalTrials.gov Identifier:||NCT00002248 History of Changes|
|Other Study ID Numbers:||081A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Antidiarrheals
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.