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:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002248
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1993
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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: | Endpoint Classification: Safety Study Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130309094706im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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.
![](https://webarchive.library.unt.edu/web/20130309094706im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 | |
Saint Elizabeth's Hosp | |
Boston, Massachusetts, United States, 02135 | |
New England Med Ctr | |
Boston, Massachusetts, United States, 02111 | |
United States, New York | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 |
Sponsors and Collaborators
Univax Biologics Inc
![](https://webarchive.library.unt.edu/web/20130309094706im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
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)
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 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Antidiarrheals Cryptosporidiosis Diarrhea |
Acquired Immunodeficiency Syndrome Cryptosporidium Immunization, Passive |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Cryptosporidiosis Enteritis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Intestinal Diseases, Parasitic |
Parasitic Diseases Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Immunoglobulins Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 07, 2013