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	Treatment or Intervention
Meningitis, Cryptococcal HIV Infections	Drug: Fluconazole  Drug: Amphotericin B

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
Arizona
      Tucson Veterans Administration Med Ctr, Tucson,  Arizona,  85724,  United States
California
      Davies Med Ctr, San Francisco,  California,  94114,  United States
      Dr Richard Meyer, Los Angeles,  California,  90048,  United States
      Dr Paul Rothman, Sherman Oaks,  California,  91403,  United States
Delaware
      Wilmington Hosp / Med Ctr of Delaware, Wilmington,  Delaware,  19899,  United States
District of Columbia
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
Florida
      Univ of Florida College of Medicine, Gainesville,  Florida,  32610,  United States
      Univ of South Florida, Tampa,  Florida,  33612,  United States
Georgia
      DeKalb Gen Hosp, Decatur,  Georgia,  30033,  United States
      Med College of Georgia, Augusta,  Georgia,  30912,  United States
      Shallowford Hosp, Decatur,  Georgia,  30033,  United States
      Emory Univ School of Medicine, Atlanta,  Georgia,  30303,  United States
Illinois
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States
Maine
      Dr Michael Bach, Portland,  Maine,  04102,  United States
Maryland
      Univ of Maryland / Inst of Human Virology, Baltimore,  Maryland,  212011192,  United States
Massachusetts
      New England Med Ctr, Boston,  Massachusetts,  02111,  United States
      Univ Hosp, Boston,  Massachusetts,  02118,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
      Harper Hosp, Detroit,  Michigan,  48201,  United States
      Ann Arbor Veterans Administration Med Ctr, Ann Arbor,  Michigan,  48105,  United States
New Jersey
      Saint Michael's Med Ctr, Newark,  New Jersey,  07102,  United States
New York
      Columbia Univ, New York,  New York,  10032,  United States
      Jewish Hosp Ctr Affiliation, Jamaica,  New York,  11432,  United States
      Chelsea Village Med Ctr, New York,  New York,  10014,  United States
      Cabrini Med Ctr, New York,  New York,  10003,  United States
      Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York,  New York,  10037,  United States
      Albany Med College / AIDS Treatment Ctr, Albany,  New York,  12203,  United States
North Carolina
      Bowman Gray School of Medicine / North Carolina Baptist Hosp, Winston Salem,  North Carolina,  27103,  United States
Ohio
      Cincinnati Veterans Adm Med Ctr / Univ Hosp, Cincinnati,  Ohio,  452670405,  United States
Pennsylvania
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      United States Air Force Med Ctr, Lackland Air Force Base,  Texas,  782365300,  United States
      Southwest Texas Methodist Hosp, San Antonio,  Texas,  78229,  United States
      Univ TX San Antonio Health Science Ctr, San Antonio,  Texas,  78284,  United States
      Univ TX Galveston Med Branch, Galveston,  Texas,  77550,  United States
Virginia
      Richmond AIDS Consortium, Richmond,  Virginia,  23219,  United States
Washington
      Dr Philip C Craven, Tacoma,  Washington,  98405,  United States
      CHG-118 Group Health / Cooperative of Puget Sound, Seattle,  Washington,  98112,  United States
Canada, Ontario
      Saint Michael's Hosp, Toronto,  Ontario,  Canada

Study ID Numbers:  012D; 056-157
Record last reviewed:  May 1990
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002074
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08