A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
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ClinicalTrials.gov Identifier: NCT00002277 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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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, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 ClinicalTrials.gov 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 |
ClinicalTrials.gov Identifier: | NCT00002277 History of Changes |
Other Study ID Numbers: |
012N 056-173 |
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:
Mycoses Neoplasms Neutropenia Fluconazole Amphotericin B |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Mycoses Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Fluconazole 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 Amebicides Antiprotozoal Agents Antiparasitic Agents |