Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002074
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1990
  Purpose

To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.


Condition Intervention
Meningitis, Cryptococcal
HIV Infections
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 Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

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:

  • Antivirals such as zidovudine.
  • Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
  • Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry.

Concurrent Treatment:

Allowed:

  • Radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must be oriented to person, place, and time, and able to give written informed consent.

  • Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of Cryptococcus neoformans from lumbar cerebrospinal fluid (CSF) culture within 6 months prior to entry.
  • Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or in combination with flucytosine) during primary therapy.
  • Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 6 weeks of completion of primary amphotericin B therapy. Patients may receive maintenance amphotericin B during the period between completion of primary therapy and study entry.

Prior Medication:

Allowed:

  • Antivirals such as zidovudine (AZT).
  • Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.

Concurrent Medication:

Excluded:

  • Ketoconazole.
  • Fluconazole.
  • Itraconazole.
  • Miconazole.
  • Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis.
  • Intrathecal amphotericin B.
  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.

Concurrent Treatment:

Excluded:

  • Lymphocyte replacement.

Patients with the following are excluded:

  • Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Inability to take oral medications reliably.

Prior Medication:

Excluded:

  • Ketoconazole.
  • Fluconazole.
  • Itraconazole.
  • Miconazole.
  • Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis.
  • Intrathecal amphotericin B.
  • Coumarin-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.

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: NCT00002074

  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
Dr Richard Meyer
Los Angeles, California, United States, 90048
Davies Med Ctr
San Francisco, California, United States, 94114
Dr Paul Rothman
Sherman Oaks, California, United States, 91403
United States, Delaware
Wilmington 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 Florida College of Medicine
Gainesville, Florida, United States, 32610
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
Shallowford Hosp
Decatur, Georgia, United States, 30033
DeKalb Gen Hosp
Decatur, Georgia, United States, 30033
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Maine
Dr Michael Bach
Portland, Maine, United States, 04102
United States, Maryland
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, New Jersey
Saint Michael's Med Ctr
Newark, New Jersey, United States, 07102
United States, New York
Albany Med College / AIDS Treatment Ctr
Albany, New York, United States, 12203
Jewish Hosp Ctr Affiliation
Jamaica, New York, United States, 11432
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
Columbia Univ
New York, New York, United States, 10032
Chelsea Village Med Ctr
New York, New York, United States, 10014
Cabrini Med Ctr
New York, New York, United States, 10003
United States, North Carolina
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, United States, 452670405
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
United States Air Force Med Ctr
Lackland Air Force Base, Texas, United States, 782365300
Southwest Texas Methodist Hosp
San Antonio, Texas, United States, 78229
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
Dr Philip C Craven
Tacoma, Washington, United States, 98405
Canada, Ontario
Saint Michael's Hosp
Toronto, Ontario, Canada
Sponsors and Collaborators
Pfizer
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002074     History of Changes
Other Study ID Numbers: 012D, 056-157
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
Fluconazole
Acquired Immunodeficiency Syndrome
Amphotericin B

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Syndrome
Immunologic Deficiency Syndromes
Meningitis
Meningitis, Cryptococcal
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Disease
Pathologic Processes
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Fluconazole
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014