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

This study has been completed.

Sponsored by:	Stolle Milk Biologic International
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002264

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)

MedlinePlus related topics: AIDS Cryptosporidiosis Diarrhea

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

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

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

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

Study placed in the following topic categories:

Protozoan Infections
Sexually Transmitted Diseases, Viral
Diarrhea
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Intestinal Diseases
Immunologic Deficiency Syndromes
Virus Diseases
Antibodies

Cryptosporidiosis
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Parasitic Diseases
Intestinal Diseases, Parasitic
Retroviridae Infections
Immunoglobulins

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Coccidiosis
Physiological Effects of Drugs

Lentivirus Infections
Parasitic Diseases, Animal
Protozoan Infections, Animal
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009