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Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002010
  Purpose

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 Intervention
Meningitis
HIV Infections
Drug: Fluconazole

Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study
Official Title: Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002010

Locations
United States, Arizona
Tucson Veterans Administration Med Ctr
Tucson, Arizona, United States, 85724
United States, California
HIV Research Group
San Diego, California, United States, 92102
United States, Texas
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

Study ID Numbers: 012P, 056-170
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002010     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Meningitis
Fluconazole
Coccidioidin
Acquired Immunodeficiency Syndrome
Coccidioidomycosis

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Infection
Meningitis
Mycoses
Antifungal Agents
Therapeutic Uses
Central Nervous System Fungal Infections
Retroviridae Infections
Fluconazole
RNA Virus Infections
Meningitis, Fungal
Immune System Diseases
Acquired Immunodeficiency Syndrome
Nervous System Diseases
Central Nervous System Diseases
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Central Nervous System Infections
HIV Infections
Sexually Transmitted Diseases
Coccidioidomycosis
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010