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Clinical Trials

MainTitle

Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002038

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: June 1996
History of Changes
Purpose

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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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: NCT00002038

Locations

United States, Connecticut
Pfizer Central Research
Groton, Connecticut, United States, 06340

Sponsors and Collaborators

Pfizer
More Information

More Information


Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00002038   History of Changes  
Other Study ID Numbers: 012C  
  056-152  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Mycoses
Drugs, Investigational
Fluconazole

Additional relevant MeSH terms:
HIV Infections
Mycoses
Candidiasis
Fluconazole
Antifungal Agents
Miconazole

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.