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

Condition	Treatment or Intervention
Cryptosporidiosis HIV Infections	Drug: Azithromycin

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

California
      UCSD Med Ctr, San Diego,  California,  92103,  United States
      Infectious Disease Med Group, Oakland,  California,  94609,  United States
New York
      Cornell Univ Med Ctr, New York,  New York,  10021,  United States
Tennessee
      Univ of Tennessee, Memphis,  Tennessee,  38103,  United States

Study ID Numbers:  058F; 066-143
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002082
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08