The study is intended to examine the efficacy of fluconazole for the treatment of coccidioidal meningitis in patients with new onset of infection, relapse of previous infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined.

Condition	Treatment or Intervention
Meningitis HIV Infections	Drug: Fluconazole

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Immunosuppressive therapy including corticosteroids and/or cytotoxic agents.
• Antiviral therapy (e.g., zidovudine (AZT)).
• Prophylaxis for Pneumocystis carinii pneumonia (PCP).
• Any exceptions to use of concomitant medications must be approved by Pfizer Central Research prior to study entry.

Concurrent Treatment: Allowed:

• Radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must:

• Be clinically judged to be in need of treatment for coccidioidal meningitis.
• Have > 1 week life expectancy.
• Allowed:
• Immunocompromised patients.
• Patients with renal disease will have the dose of fluconazole adjusted and serum levels may be monitored.

Prior Medication: Allowed:

• Amphotericin B.
• Ketoconazole.
• Miconazole.

Exclusion Criteria

Co-existing Condition: Patients with the following conditions or symptoms are excluded:

• Current antifungal infection that is responding to another agent. Findings of improvement include one of the following, while on other therapy (without subsequent relapse of the item):
• CSF culture conversion from positive to negative.
• OR
• CSF antibody titer decrease of at least one dilution.
• OR
• Improvement in signs and symptoms of meningitis.
• Have received more than minimal systemic antifungal therapy (see Patient Inclusion Criteria), unless they meet criteria for previous treatment failure or relapse. They must not have received this therapy since the time relapse or failure was documented, except for minimal antifungal therapy allowed in Patient Inclusion Criteria.
• Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
• Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.

Concurrent Medication: Excluded:

• Barbiturates.
• Phenytoin.
• Oral hypoglycemics.
• Coumadin type anticoagulants.
• Other systemic or intrathecal antifungal therapy.
• Other experimental agents with exceptions noted in concomitant medications section.
• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research prior to study entry.

Patients with the following are excluded:

• Are responding or are improving on current antifungal therapy with another agent.
• Have received more than minimal systemic antifungal therapy (see Patient Inclusion Criteria), unless they meet criteria for previous treatment failure or relapse. They must not have received this therapy since the time relapse or failure was documented, except for minimal antifungal therapy allowed in Patient Inclusion Criteria.
• Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
• Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.

Arizona
      Tucson Veterans Administration Med Ctr, Tucson,  Arizona,  85724,  United States
California
      HIV Research Group, San Diego,  California,  92102,  United States
Texas
      Audie L Murphy Veterans Administration Hosp, San Antonio,  Texas,  78284,  United States

Study ID Numbers:  012P; 056-170
Record last reviewed:  February 1992
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002010
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08