Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
2 other identifiers
interventional
N/A
1 country
4
Brief Summary
To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (4)
Infectious Disease Med Group
Oakland, California, 94609, United States
UCSD Med Ctr
San Diego, California, 92103, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Univ of Tennessee
Memphis, Tennessee, 38103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04