Full Text View
Tabular View
No Study Results Posted
Related Studies
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002277
  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 III

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

Resource links provided by NLM:

  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
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

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

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

Study placed in the following topic categories:
Abelcet
Fluconazole
Amphotericin B
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Liposomal amphotericin B
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents
Mycoses
Neutropenia
HIV Infections
Antifungal Agents
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Abelcet
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Antiprotozoal Agents
Slow Virus Diseases
Infection
Liposomal amphotericin B
Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides
Retroviridae Infections
Fluconazole
Amphotericin B
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on July 02, 2009