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

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.