Washington, District of Columbia 20037

  • HIV Infections

Purpose:

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.


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.


Study is Available At:


Original ID:

012F


NCT ID:

NCT00002305


Secondary ID:

056-159


Study Acronym:


Brief Title:

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


Official Title:

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:December 1989
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Flucytosine
Intervention Type:Drug
Name:Fluconazole
Intervention Type:Drug
Name:Amphotericin B

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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