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Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002075
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1989
  Purpose

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.


Condition Intervention
Meningitis, Cryptococcal
HIV Infections
Drug: Flucytosine
Drug: Fluconazole
Drug: Amphotericin B

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Immunosuppressant therapy.
  • Antiviral such as zidovudine.
  • Radiation therapy for mucocutaneous Kaposi's sarcoma.
  • Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.

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.
  • Antivirals such as zidovudine (AZT).
  • Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.

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:
  • Received more 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:
  • More than 1 mg/kg/wk amphotericin B.

Prior Treatment:

Excluded:

  • Lymphocyte replacement.
  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: NCT00002075

Locations
United States, California
Dr Robert Larsen
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002075     History of Changes
Other Study ID Numbers: 012G, 056-159A
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:
AIDS-Related Opportunistic Infections
Meningitis
Cryptococcosis
Drug Therapy, Combination
Fluconazole
Flucytosine
Acquired Immunodeficiency Syndrome
Amphotericin B

Additional relevant MeSH terms:
Cryptococcosis
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Meningitis
Meningitis, Cryptococcal
Central Nervous System Diseases
Central Nervous System Fungal Infections
Central Nervous System Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Meningitis, Fungal
Mycoses
Nervous System Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Amphotericin B
Fluconazole
Flucytosine
Liposomal amphotericin B
14-alpha Demethylase Inhibitors
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on November 25, 2014