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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002306

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Fluconazole	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
3	Univ of South Florida	Tampa	Florida	United States	33612
4	Emory Univ School of Medicine	Atlanta	Georgia	United States	30303
5	Med College of Georgia	Augusta	Georgia	United States	30912
6	Univ Hosp	Boston	Massachusetts	United States	02118
7	Ann Arbor Veterans Administration Med Ctr	Ann Arbor	Michigan	United States	48105
8	Washington Univ School of Medicine	St. Louis	Missouri	United States	63108
9	Bronx Veterans Administration / Mount Sinai Hosp	Bronx	New York	United States	10468
10	Saint Luke's - Roosevelt Hosp Ctr	New York	New York	United States	10025
11	Cincinnati Veterans Adm Med Ctr / Univ Hosp	Cincinnati	Ohio	United States	452670405
12	United States Air Force Med Ctr	Lackland Air Force Base	Texas	United States	782365300
13	Southwest Texas Methodist Hosp	San Antonio	Texas	United States	78229
14	Univ TX San Antonio Health Science Ctr	San Antonio	Texas	United States	78284