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Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
This study has been completed.
Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002038
  Purpose

The primary purpose of this protocol is to provide fluconazole for the treatment of individual patients who require therapy for serious or life-threatening systemic fungal infection, who have failed on conventional antifungal therapy or have had unacceptable reactions to conventional antifungal therapy, and who are ineligible for other established fluconazole clinical trial protocols.


Condition Intervention
Candidiasis
Mycoses
HIV Infections
Drug: Fluconazole

MedlinePlus related topics: AIDS Fungal Infections Yeast Infections
Drug Information available for: Clotrimazole Miconazole Miconazole nitrate Tioconazole Fluconazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Dose Comparison
Official Title: Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria

Co-existing Condition:

A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole.

A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole.

AMENDED:

  • 900207 Open only to unapproved indications and/or age ranges.
  • Original design:
  • Patients with clinically established serious or life-threatening systemic fungal disease will be considered if conventional fungal therapy is not an acceptable alternative. Unacceptability of conventional therapy is defined as:
  • Failure of conventional therapy to control or eradicate infection after appropriate trial(s) of generally accepted regimen(s).
  • Serious and unacceptable untoward reaction(s) to conventional antifungal therapy.
  • OR A major contraindication to the use of conventional antifungal therapy.
  • The patient must be ineligible or have no access to other established fluconazole investigational protocols. The final judgment of patient acceptability for inclusion lies with the Pfizer Clinical Monitor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002038

Locations
United States, Connecticut
Pfizer Central Research
Groton, Connecticut, United States, 06340
Sponsors and Collaborators
Pfizer
  More Information

Study ID Numbers: 012C, 056-152
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002038  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycoses
Drugs, Investigational
Fluconazole

Study placed in the following topic categories:
Fluconazole
Sexually Transmitted Diseases, Viral
Candidiasis
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009