A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

HIV Infections Clinical Trial

Official title:

Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002306
• Other study ID #: 012I
• Secondary ID: 056-161
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Immunosuppressant therapy.

• Antiviral therapy such as zidovudine.

• Prophylaxis for Pneumocystis carinii pneumonia.

• Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

• Radiation therapy for mucocutaneous Kaposi's sarcoma.

Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.

• Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans.

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

• Each individual patient must be approved by Pfizer Central Research prior to study entry.

Prior Medication:

Allowed:

• Immunosuppressant therapy.

• Antiviral therapy such as zidovudine.

• Prophylaxis for Pneumocystis carinii pneumonia.

• Aerosolized pentamidine.

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 or azoles.

• Moderate or severe liver disease.

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 or azoles.

• Moderate or severe liver disease.

• Satisfactory response to amphotericin B and have received a total amphotericin B dose of 15 mg/kg or more since CSF culture documentation of the current episode of acute cryptococcal meningitis.

• Life expectancy of < 2 weeks.

Prior Medication:

Excluded:

• Coumadin-type anticoagulants.

• Oral hypoglycemics.

• Barbiturates.

• Phenytoin.

• Immunostimulants.

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

Prior Treatment:

Excluded:

• Lymphocyte replacement.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Fluconazole

Locations

Country	Name	City	State
United States	Ann Arbor Veterans Administration Med Ctr	Ann Arbor	Michigan
United States	Emory Univ School of Medicine	Atlanta	Georgia
United States	Med College of Georgia	Augusta	Georgia
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Univ Hosp	Boston	Massachusetts
United States	Bronx Veterans Administration / Mount Sinai Hosp	Bronx	New York
United States	Cincinnati Veterans Adm Med Ctr / Univ Hosp	Cincinnati	Ohio
United States	United States Air Force Med Ctr	Lackland Air Force Base	Texas
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Southwest Texas Methodist Hosp	San Antonio	Texas
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	Washington Univ School of Medicine	St. Louis	Missouri
United States	Univ of South Florida	Tampa	Florida
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,