Back to resultsThe Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea
Primary Purpose
Cryptosporidiosis, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryptosporidium Immune Whey Protein Concentrate (Bovine)
Sponsored by
About this trial
This is an interventional treatment trial for Cryptosporidiosis
Eligibility Criteria
Inclusion Criteria Patients must have: Diagnosis of diarrhea associated with intestinal cryptosporidiosis. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Survival time projected to be < 9 weeks. Inability to tolerate any oral intake. Known allergy or intolerance to milk products. Organic mental syndrome precluding informed consent or following directions. Patients with the following are excluded: Survival time projected to be < 9 weeks. Inability to tolerate any oral intake. Known allergy or intolerance to milk products. Organic mental syndrome precluding informed consent or following directions.
Sites / Locations
- Saint Luke's - Roosevelt Hosp Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002264
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Stolle Milk Biologic International
1. Study Identification
Unique Protocol Identification Number
NCT00002264
Brief Title
The Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea
Official Title
Efficacy of Cow's Milk Immune Globulin in the Treatment of Chronic Intestinal Cryptosporidiosis in Patients With AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stolle Milk Biologic International
4. Oversight
5. Study Description
Brief Summary
To examine the efficacy of cow's milk immune globulin in the treatment of diarrhea due to chronic intestinal cryptosporidiosis in patients with AIDS. The secondary end points of the study involve functional improvement which will be determined from nutritional and absorption studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptosporidiosis, HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cryptosporidium Immune Whey Protein Concentrate (Bovine)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
Diagnosis of diarrhea associated with intestinal cryptosporidiosis.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Survival time projected to be < 9 weeks.
Inability to tolerate any oral intake.
Known allergy or intolerance to milk products.
Organic mental syndrome precluding informed consent or following directions.
Patients with the following are excluded:
Survival time projected to be < 9 weeks.
Inability to tolerate any oral intake.
Known allergy or intolerance to milk products.
Organic mental syndrome precluding informed consent or following directions.
Facility Information:
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea
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