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

Completed · Phase 3

Conditions studied: Mycoses, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002277

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dr Layne Gentry — Houston, Texas, United States
• Dr Temple Williams — Houston, Texas, United States
• M D Anderson Cancer Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

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