The Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002264
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1999
  Purpose

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.


Condition Intervention
Cryptosporidiosis
HIV Infections
Drug: Cryptosporidium Immune Whey Protein Concentrate (Bovine)

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Efficacy of Cow's Milk Immune Globulin in the Treatment of Chronic Intestinal Cryptosporidiosis in Patients With AIDS

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00002264

Locations
United States, New York
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Sponsors and Collaborators
Stolle Milk Biologic International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002264     History of Changes
Other Study ID Numbers: 068A, WPC-S123
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cryptosporidiosis
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
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014