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Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs

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ClinicalTrials.gov Identifier: NCT00002328
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:
To provide azithromycin for the treatment of individual patients with proven cryptosporidiosis whose disease has persisted or progressed despite prior therapies.

Condition or disease Intervention/treatment Phase
Cryptosporidiosis HIV Infections Drug: Azithromycin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Oral/Intravenous Azithromycin in the Treatment of Cryptosporidiosis in Patients Whose Disease Has Not Been Controlled by Conventional Therapy

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • Cryptosporidiosis infection.
  • Life expectancy of at least 1 week.
  • Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic or other therapies for cryptosporidiosis.
  • Consent of parent or guardian for patients under the legal age of consent. Patients with documented favorable response to azithromycin under Pfizer protocol 066-143 may receive maintenance therapy under this protocol.

Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain hydration may receive IV azithromycin after approval by the clinical monitor. Patients whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose disease shows no improvement after 4 weeks of oral therapy will also be considered for a trial period of intravenous azithromycin.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known hypersensitivity or significant intolerance to macrolide antibiotics.
  • Eligibility and current treatment at a medical center performing study 066-143, another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.

Required:

  • Must have failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic therapies for cryptosporidiosis.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002328


Locations
United States, Connecticut
Pfizer Central Research
Groton, Connecticut, United States, 06340
Sponsors and Collaborators
Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00002328     History of Changes
Other Study ID Numbers: 058J
066-167S
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Antidiarrheals
Cryptosporidiosis
Diarrhea
Acquired Immunodeficiency Syndrome
Azithromycin

Additional relevant MeSH terms:
HIV Infections
Cryptosporidiosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections, Animal
Parasitic Diseases, Animal
Coccidiosis
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases