Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cryptosporidiosis; HIV Infections
Intervention: Azithromycin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
Summary
To provide azithromycin for the treatment of individual patients with proven
cryptosporidiosis whose disease has persisted or progressed despite prior therapies.
Clinical Details
Official title: Oral/Intravenous Azithromycin in the Treatment of Cryptosporidiosis in Patients Whose Disease Has Not Been Controlled by Conventional Therapy
Study design: Treatment, Dose Comparison
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
Co-existing Condition:
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.
Required:
- Must have failed or been intolerant to prior therapy with standard antidiarrheal or
antibiotic therapies for cryptosporidiosis.
Locations and Contacts
Pfizer Central Research, Groton, Connecticut 06340, United States
Additional Information
Last updated: June 23, 2005
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