A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

HIV Infections Clinical Trial

Official title:

Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002277
• Other study ID #: 012N
• Secondary ID: 056-173
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1993
• 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

To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Immunostimulants under studies carried out under an IRB approved protocol.

• Treatments of intercurrent non-fungal infection.

• Allowed but requires monitoring during fluconazole therapy:

• Barbiturates.

• Phenytoin.

• Oral hypoglycemics.

• Coumarin-type anticoagulants.

Patients must have the following:

• Diagnosis or presumption of fungal infection under defined conditions.

• Written informed consent either from the patient or the patient's legal guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Burns > 30 percent of the body.

• Diagnosis of AIDS or AIDS related complex (ARC).

• HIV positive unless they have a malignancy.

• History of allergy to or intolerance of imidazoles or azoles.

• Moderate to severe liver disease as defined by specific lab values.

• Unlikely to survive more than 24 hours.

• Evidence of previous amphotericin B sensitivity.

Concurrent Medication:

Excluded:

• Concomitant antifungal agents other than the study drugs.

• Immunostimulants, except for studies carried out under an IRB approved protocol.

Concurrent Treatment:

Excluded:

• Lymphocyte replacements.

Patients with the following are excluded:

• Defined disease conditions listed in Exclusion Co-Existing Conditions.

• Unlikely to survive more than 24 hours.

• Previous participation in this study; reentry for the same infection is not allowed.

• Known to be unable to take amphotericin B due to acute toxicities.

Prior Medication:

Excluded:

• Previous fluconazole therapy for this infection.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Infection
• Mycoses

Intervention

Drug:
• Fluconazole

• Amphotericin B

Locations

Country	Name	City	State
United States	Dr Layne Gentry	Houston	Texas
United States	Dr Temple Williams	Houston	Texas
United States	M D Anderson Cancer Ctr	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,