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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002277
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief 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.

Condition or disease Intervention/treatment Phase
Mycoses HIV Infections Drug: Fluconazole Drug: Amphotericin B Phase 3

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • Concomitant antifungal agents other than the study drugs.
  • Immunostimulants, except for studies carried out under an IRB approved protocol.

Concurrent Treatment:


  • 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:


  • Previous fluconazole therapy for this infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002277

United States, Texas
Dr Layne Gentry
Houston, Texas, United States, 77030
Dr Temple Williams
Houston, Texas, United States, 77030
M D Anderson Cancer Ctr
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pfizer Identifier: NCT00002277     History of Changes
Other Study ID Numbers: 012N
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 1993

Keywords provided by NIH AIDS Clinical Trials Information Service:
Amphotericin B

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Antiprotozoal Agents
Antiparasitic Agents