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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002010
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00002010     History of Changes
Other Study ID Numbers: 012P
056-170
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: February 1992

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

Additional relevant MeSH terms:
HIV Infections
Meningitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors