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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002277
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1993
  Purpose

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 Intervention Phase
Mycoses
HIV Infections
Drug: Fluconazole
Drug: Amphotericin B
Phase 3

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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002277

Locations
United States, Texas
M D Anderson Cancer Ctr
Houston, Texas, United States, 77030
Dr Layne Gentry
Houston, Texas, United States, 77030
Dr Temple Williams
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002277     History of Changes
Other Study ID Numbers: 012N, 056-173
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycoses
Neoplasms
Neutropenia
Fluconazole
Amphotericin B

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Mycoses
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Fluconazole
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 18, 2014