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

Completed · Not applicable

Conditions studied: Cryptosporidiosis, HIV Infections

In brief

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

Key facts

Study ID

NCT00002082

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Cancer chemotherapy (including therapy for Kaposi's sarcoma).
• Not expected to comply with the requirements of the protocol, in the opinion of the investigator.

Where it is running

• 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

Full record on ClinicalTrials.gov

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