A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00002305
• Date of registration: 02/11/1999
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
• Scientific title: Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
• Date of first enrolment: October 1997
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002305
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Canada, United States

Key inclusion & exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Immunosuppressant therapy.

- Antiviral therapy such as zidovudine.

- Prophylaxis for Pneumocystis carinii pneumonia.

Concurrent Treatment:

Allowed:

- Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written informed consent must be obtained for each patient, either from the patient
himself or from the patient's legal guardian.

- No prior systemic antifungal therapy for cryptococcosis.

- Relapse after prior therapy.

- Success of prior therapy must have been documented by negative cerebrospinal fluid
(CSF) culture at the end of therapy. Following prior therapy, such patients may not
have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into
study.

Prior Medication:

Allowed:

- Immunosuppressant therapy.

- Antiviral therapy (such as zidovudine).

- Prophylaxis for Pneumocystis carinii pneumonia.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

- Evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.

- History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.

- Moderate or severe liver disease.

- Comatose.

- Unlikely to survive more than 2 weeks.

- Any exceptions to these prohibitions of concomitant medications must be approved by
Pfizer Central Research.

Concurrent Medication:

Excluded:

- Coumadin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drugs or approved (licensed) drugs for investigational indications.

- Any exceptions to these prohibitions of concomitant medications must be approved by
Pfizer Central Research.

- Excluded within 4 weeks of study entry:

- Greater than 1 mg/kg/wk amphotericin B.

Concurrent Treatment:

Excluded:

- Lymphocyte replacement.

Patients with the following are excluded:

- Evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.

- History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.

- Moderate or severe liver disease.

- Comatose.

- Unlikely to survive more than 2 weeks.

Prior Medication:

Excluded:

- Coumadin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drugs or approved (licensed) drugs for investigational indications.

- Excluded within 4 weeks of study entry:

- Greater than 1 mg/kg/wk amphotericin B.

Prior Treatment:

Excluded:

- Lymphocyte replacement.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Meningitis, Cryptococcal

Intervention(s)

Drug: Fluconazole

Drug: Flucytosine

Drug: Amphotericin B

Secondary ID(s)

012F

056-159

Source(s) of Monetary Support

Please refer to primary and secondary sponsors