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

NCT00002075

Last updated date
Study Location
Dr Robert Larsen
Los Angeles, California, 90033, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cryptococcal Meningitis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
Official Title  ICMJE Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
Brief Summary To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Meningitis, Cryptococcal
  • HIV Infections
Intervention  ICMJE
  • Drug: Flucytosine
  • Drug: Fluconazole
  • Drug: Amphotericin B
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002075
Other Study ID Numbers  ICMJE 012G
056-159A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date September 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP