- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002082
Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
June 23, 2005 updated by: Pfizer
To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oakland, California, United States, 94609
- Infectious Disease Med Group
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San Diego, California, United States, 92103
- UCSD Med Ctr
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-
New York
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New York, New York, United States, 10021
- Cornell Univ Med Ctr
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Tennessee
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Memphis, Tennessee, United States, 38103
- Univ of Tennessee
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 1996
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Diseases, Parasitic
- Parasitic Diseases
- Protozoan Infections, Animal
- Parasitic Diseases, Animal
- Coccidiosis
- Protozoan Infections
- Slow Virus Diseases
- HIV Infections
- Cryptosporidiosis
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Anti-Infective Agents
- Anti-Bacterial Agents
- Azithromycin
Other Study ID Numbers
- 058F
- 066-143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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