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


Phase 3
13 Years
N/A
Not Enrolling
Both
Mycoses, HIV Infections

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Trial Information

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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

012N

NCT ID:

NCT00002277

Start Date:

Completion Date:

Related Keywords:

  • Mycoses
  • HIV Infections
  • Mycoses
  • Neoplasms
  • Neutropenia
  • Fluconazole
  • Amphotericin B
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Mycoses

Name

Location

M D Anderson Cancer CtrHouston, Texas  77030
Dr Layne GentryHouston, Texas  77030
Dr Temple WilliamsHouston, Texas  77030