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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002038
• Other study ID #: 012C
• Secondary ID: 056-152
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• HIV Infections
• Mycoses

Intervention

Drug:
• Fluconazole

Locations

Country	Name	City	State
United States	Pfizer Central Research	Groton	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,