To provide azithromycin for the treatment of individual patients with proven
cryptosporidiosis whose disease has persisted or progressed despite prior therapies.
Patients must have:
- Cryptosporidiosis infection.
- Life expectancy of at least 1 week.
- Failed or been intolerant to prior therapy with standard antidiarrheal or antibiotic
or other therapies for cryptosporidiosis.
- Consent of parent or guardian for patients under the legal age of consent. Patients
with documented favorable response to azithromycin under Pfizer protocol 066-143 may
receive maintenance therapy under this protocol.
Patients with persistent diarrhea requiring intravenous (IV) fluid therapy to maintain
hydration may receive IV azithromycin after approval by the clinical monitor. Patients
whose disease worsens despite a minimum of 2 weeks of oral therapy or patients whose
disease shows no improvement after 4 weeks of oral therapy will also be considered for a
trial period of intravenous azithromycin.
Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity or significant intolerance to macrolide antibiotics.
- Eligibility and current treatment at a medical center performing study 066-143,
another study of azithromycin for treatment of cryptosporidiosis in AIDS patients.
- Must have failed or been intolerant to prior therapy with standard antidiarrheal or
antibiotic therapies for cryptosporidiosis.