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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002328

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1998
History of Changes
Purpose

Purpose

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

Condition Intervention
Cryptosporidiosis
HIV Infections

Drug : Azithromycin

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

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

Eligibility

Eligibility

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

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: NCT00002328

Locations

United States, Connecticut
Pfizer Central Research
Groton, Connecticut, United States, 06340

Sponsors and Collaborators

Pfizer
More Information

More Information


Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00002328   History of Changes  
Other Study ID Numbers: 058J  
  066-167S  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Antidiarrheals
Cryptosporidiosis
Diarrhea
Acquired Immunodeficiency Syndrome
Azithromycin

Additional relevant MeSH terms:
HIV Infections
Cryptosporidiosis

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.