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

Primary Purpose

Meningitis, Cryptococcal, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Flucytosine
Fluconazole
Amphotericin B
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Tucson Veterans Administration Med Ctr
  • UCLA CARE Ctr
  • Dr Shelly Gordon
  • Dr Martin Mass
  • Dr Paul Rothman
  • Christiana Hosp / Med Ctr of Delaware
  • George Washington Univ Med Ctr
  • Univ of Miami School of Medicine
  • Univ of South Florida
  • Emory Univ School of Medicine
  • Med College of Georgia
  • DeKalb Gen Hosp
  • Northwestern Univ Med School
  • Louisiana State Univ School of Medicine
  • Tulane Univ School of Medicine
  • Dr Michael Bach
  • Univ of Maryland / Inst of Human Virology
  • Loch Raven Veterans Hosp
  • New England Med Ctr
  • Univ Hosp
  • Ann Arbor Veterans Administration Med Ctr
  • Harper Hosp
  • Henry Ford Hosp
  • Washington Univ School of Medicine
  • Albany Med College / AIDS Treatment Ctr
  • Montefiore Med Ctr / Bronx Municipal Hosp
  • Bronx Veterans Administration / Mount Sinai Hosp
  • Jewish Hosp Ctr Affiliation
  • Chelsea Village Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • Saint Luke's - Roosevelt Hosp Ctr
  • Columbia Univ
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Univ of North Carolina School of Medicine
  • Cincinnati Veterans Adm Med Ctr / Univ Hosp
  • Ohio State Univ Hosp
  • Univ of Tennessee
  • Dr Daniel Barbaro
  • Univ TX Galveston Med Branch
  • United States Air Force Med Ctr
  • Univ TX San Antonio Health Science Ctr
  • Richmond AIDS Consortium
  • CHG-118 Group Health / Cooperative of Puget Sound
  • Saint Michael's Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00002305
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Cryptococcal, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Flucytosine
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Type
Drug
Intervention Name(s)
Amphotericin B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Tucson Veterans Administration Med Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Dr Shelly Gordon
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dr Martin Mass
City
San Francisco
State/Province
California
ZIP/Postal Code
94120
Country
United States
Facility Name
Dr Paul Rothman
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Christiana Hosp / Med Ctr of Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Univ School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
DeKalb Gen Hosp
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Louisiana State Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Dr Michael Bach
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Univ of Maryland / Inst of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212011192
Country
United States
Facility Name
Loch Raven Veterans Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Univ Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Ann Arbor Veterans Administration Med Ctr
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington Univ School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Albany Med College / AIDS Treatment Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
Montefiore Med Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Bronx Veterans Administration / Mount Sinai Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Jewish Hosp Ctr Affiliation
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Chelsea Village Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Columbia Univ
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem AIDS Treatment Group / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Cincinnati Veterans Adm Med Ctr / Univ Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Ohio State Univ Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Dr Daniel Barbaro
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
United States Air Force Med Ctr
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
782365300
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
CHG-118 Group Health / Cooperative of Puget Sound
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Saint Michael's Hosp
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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