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

NCT ID: NCT00002264

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Cryptosporidiosis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Cryptosporidium Immune Whey Protein Concentrate (Bovine)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stolle Milk Biologic International

INDUSTRY

Sponsor Role lead

Locations

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Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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WPC-S123

Identifier Type: -

Identifier Source: secondary_id

068A

Identifier Type: -

Identifier Source: org_study_id