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Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002010
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1992

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002010 on ClinicalTrials.gov Archive Site
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Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

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.

Not Provided
Interventional
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Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • Meningitis
  • HIV Infections
Drug: Fluconazole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002010
012P, 056-170
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Pfizer
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NIH AIDS Clinical Trials Information Service
February 1992

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP