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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002305
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1989
  Purpose

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


Condition Intervention
Meningitis, Cryptococcal
HIV Infections
Drug: Flucytosine
Drug: Fluconazole
Drug: Amphotericin B

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002305

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Tucson Veterans Administration Med Ctr
Tucson, Arizona, United States, 85724
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Dr Shelly Gordon
San Francisco, California, United States, 94115
Dr Martin Mass
San Francisco, California, United States, 94120
Dr Paul Rothman
Sherman Oaks, California, United States, 91403
United States, Delaware
Christiana Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Univ of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory Univ School of Medicine
Atlanta, Georgia, United States, 30303
Med College of Georgia
Augusta, Georgia, United States, 30912
DeKalb Gen Hosp
Decatur, Georgia, United States, 30033
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
Louisiana State Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maine
Dr Michael Bach
Portland, Maine, United States, 04102
United States, Maryland
Loch Raven Veterans Hosp
Baltimore, Maryland, United States, 21218
Univ of Maryland / Inst of Human Virology
Baltimore, Maryland, United States, 212011192
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
Univ Hosp
Boston, Massachusetts, United States, 02118
United States, Michigan
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, United States, 48105
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Harper Hosp
Detroit, Michigan, United States, 48201
United States, Missouri
Washington Univ School of Medicine
St. Louis, Missouri, United States, 63108
United States, New York
Albany Med College / AIDS Treatment Ctr
Albany, New York, United States, 12203
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, United States, 10467
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, United States, 10468
Jewish Hosp Ctr Affiliation
Jamaica, New York, United States, 11432
Columbia Univ
New York, New York, United States, 10032
Chelsea Village Med Ctr
New York, New York, United States, 10014
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
United States, North Carolina
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, United States, 452670405
Ohio State Univ Hosp
Columbus, Ohio, United States, 43210
United States, Tennessee
Univ of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Dr Daniel Barbaro
Dallas, Texas, United States, 75235
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
United States Air Force Med Ctr
Lackland Air Force Base, Texas, United States, 782365300
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23219
United States, Washington
CHG-118 Group Health / Cooperative of Puget Sound
Seattle, Washington, United States, 98112
Canada, Ontario
Saint Michael's Hosp
Toronto, Ontario, Canada
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002305     History of Changes
Other Study ID Numbers: 012F, 056-159
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Meningitis
Cryptococcosis
Drug Therapy, Combination
Fluconazole
Flucytosine
Acquired Immunodeficiency Syndrome
Amphotericin B

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Meningitis
Meningitis, Cryptococcal
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Amphotericin B
Liposomal amphotericin B
Fluconazole
Flucytosine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014