A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

NCT00002306

Last updated date
Study Location
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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1-800-718-1021

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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
13 + 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 therapy such as zidovudine.

- Prophylaxis for Pneumocystis carinii pneumonia.

- Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

- Radiation therapy for mucocutaneous Kaposi's sarcoma.

Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.

- Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans.

- Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

- Each individual patient must be approved by Pfizer Central Research prior to study entry.

Prior Medication:

Allowed:

- Immunosuppressant therapy.

- Antiviral therapy such as zidovudine.

- Prophylaxis for Pneumocystis carinii pneumonia.

- Aerosolized 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 or azoles.


- Moderate or severe liver disease.


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 or azoles.


- Moderate or severe liver disease.


- Satisfactory response to amphotericin B and have received a total amphotericin B dose
of 15 mg/kg or more since CSF culture documentation of the current episode of acute
cryptococcal meningitis.


- Life expectancy of < 2 weeks.


Prior Medication:


Excluded:


- Coumadin-type anticoagulants.


- Oral hypoglycemics.


- Barbiturates.


- Phenytoin.


- Immunostimulants.


- Investigational drugs or approved (licensed) drugs for investigational indications.


Prior Treatment:


Excluded:


- Lymphocyte replacement.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
Official Title  ICMJE Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B
Brief Summary To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.
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: Fluconazole
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 therapy such as zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.
  • Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

  • Radiation therapy for mucocutaneous Kaposi's sarcoma.

Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.

  • Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans.
  • Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
  • Each individual patient must be approved by Pfizer Central Research prior to study entry.

Prior Medication:

Allowed:

  • Immunosuppressant therapy.
  • Antiviral therapy such as zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.
  • Aerosolized 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 or azoles.
  • Moderate or severe liver disease.

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 or azoles.
  • Moderate or severe liver disease.
  • Satisfactory response to amphotericin B and have received a total amphotericin B dose of 15 mg/kg or more since CSF culture documentation of the current episode of acute cryptococcal meningitis.
  • Life expectancy of < 2 weeks.

Prior Medication:

Excluded:

  • Coumadin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.

Prior Treatment:

Excluded:

  • Lymphocyte replacement.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, 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 NCT00002306
Other Study ID Numbers  ICMJE 012I
056-161
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 February 1990

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