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Clinical Trials

MainTitle

Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002082

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
Purpose

Purpose

To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.

Condition Intervention
Cryptosporidiosis
HIV Infections

Drug : Azithromycin

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
Concurrent Medication:
Allowed:

  • Zidovudine.
  • Antidiarrheal medication with imodium or paregoric only.

  • Patients must have:
  • HIV infection.
  • Intestinal cryptosporidiosis proven by stool microscopy on at least two occasions prior to study enrollment.
  • Life expectancy of at least 2 weeks by clinical assessment. In states where the legal age of consent for medical procedures is 21 years, patients below the age of 21 must have consent of parent or guardian.

  • Prior Medication:
    Allowed:
  • Zidovudine.

  • Exclusion Criteria
    Co-existing Condition:
    Patients with the following symptoms and conditions are excluded:
  • Known hypersensitivity or significant intolerance to macrolide antibiotics.
  • Marked abnormalities of liver or renal function.
  • Causes for diarrhea other than, or in addition to, cryptosporidiosis.
  • Inability to receive oral medication.

  • Concurrent Medication:
    Excluded:
  • Cancer chemotherapy (including therapy for Kaposi's sarcoma).
  • Any drug or biologic preparation (e.g., bovine colostrum, paromomycin, spiramycin, somatostatin) with possible anticryptosporidial activity.
  • Immunostimulant or lymphocyte replacement therapy.

  • Prior Medication:
    Excluded:
  • Another investigational drug within 7 days prior to study enrollment (investigational medications available through a treatment IND will be allowed with the approval of the sponsor, the treatment IND sponsor, and the Pfizer clinical monitor).
  • Immunostimulant or lymphocyte replacement therapy.
  • Cancer chemotherapy (including therapy for Kaposi's sarcoma).
Not expected to comply with the requirements of the protocol, in the opinion of the investigator.

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: NCT00002082

Locations

United States, California
Infectious Disease Med Group
Oakland, California, United States, 94609
UCSD Med Ctr
San Diego, California, United States, 92103
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
United States, Tennessee
Univ of Tennessee
Memphis, Tennessee, United States, 38103

Sponsors and Collaborators

Pfizer
More Information

More Information


Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00002082   History of Changes  
Other Study ID Numbers: 058F  
  066-143  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Cryptosporidiosis
Acquired Immunodeficiency Syndrome
Azithromycin

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Cryptosporidiosis

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.