Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
NCT ID: NCT00002082
Last Updated: 2005-06-24
Study Results
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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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Azithromycin
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Infectious Disease Med Group
Oakland, California, United States
UCSD Med Ctr
San Diego, California, United States
Cornell Univ Med Ctr
New York, New York, United States
Univ of Tennessee
Memphis, Tennessee, United States
Countries
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Other Identifiers
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066-143
Identifier Type: -
Identifier Source: secondary_id
058F
Identifier Type: -
Identifier Source: org_study_id