A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
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ClinicalTrials.gov Identifier: NCT00002305 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meningitis, Cryptococcal HIV Infections | Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
- No prior systemic antifungal therapy for cryptococcosis.
- Relapse after prior therapy.
- Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.
Prior Medication:
Allowed:
- Immunosuppressant therapy.
- Antiviral therapy (such as zidovudine).
- Prophylaxis for Pneumocystis carinii pneumonia.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Comatose.
- Unlikely to survive more than 2 weeks.
- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
Concurrent Medication:
Excluded:
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
Concurrent Treatment:
Excluded:
- Lymphocyte replacement.
Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Comatose.
- Unlikely to survive more than 2 weeks.
Prior Medication:
Excluded:
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
Prior Treatment:
Excluded:
- Lymphocyte replacement.

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): NCT00002305

ClinicalTrials.gov Identifier: | NCT00002305 History of Changes |
Other Study ID Numbers: |
012F 056-159 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 1989 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Meningitis Cryptococcosis Drug Therapy, Combination |
Fluconazole Flucytosine Acquired Immunodeficiency Syndrome Amphotericin B |
Additional relevant MeSH terms:
HIV Infections Meningitis Meningitis, Cryptococcal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Central Nervous System Diseases Nervous System Diseases Meningitis, Fungal Central Nervous System Fungal Infections |
Mycoses Cryptococcosis Central Nervous System Infections Fluconazole Amphotericin B Liposomal amphotericin B Flucytosine 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 |