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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002010

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: February 1992
History of Changes
Purpose

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

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

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
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

Contacts and Locations

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, see Learn About Clinical Studies.

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

More Information


Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00002010   History of Changes  
Other Study ID Numbers: 012P  
  056-170  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

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
Fluconazole

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.