Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

NCT00002076

Last updated date
Study Location
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609, 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:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[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:

- Antiviral therapy such as zidovudine.

- Prophylaxis for Pneumocystis carinii pneumonia.

- Aerosolized 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.

- 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:

- 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, azoles, or amphotericin B.


- Moderate or severe liver disease defined by specified lab values.


- Patients who are unable to take oral medication.


- Unlikely to survive more than 2 weeks.


- Renal impairment.


Concurrent Medication:


Excluded:


- Coumarin-type anticoagulants.


- Oral hypoglycemics.


- Barbiturates.


- Phenytoin.


- Immunostimulants.


- Investigational drugs or approved (licensed) drugs for investigational indications
other than aerosolized pentamidine.


- Excluded within 4 weeks of study entry:


- Greater than 1 mg/kg/wk amphotericin B.


- Any exceptions to these prohibitions of concomitant medications must be approved by
Pfizer Central Research.


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 defined by specified lab values.


- Patients who are unable to take oral medication.


- Life expectancy of < 2 weeks.


- Any condition that may impair absorption of oral medication.


Prior Medication:


Excluded:


- Coumarin-type anticoagulants.


- Oral hypoglycemics.


- Barbiturates.


- Phenytoin.


- Immunostimulants.


- Investigational drugs or approved (licensed) drugs for investigational indications
other than aerosolized pentamidine.


- Excluded within 4 weeks of study entry:


- Greater 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 Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Official Title  ICMJE Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Brief Summary To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.
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:

  • Antiviral therapy such as zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.
  • Aerosolized 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.
  • 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:

  • 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, azoles, or amphotericin B.
  • Moderate or severe liver disease defined by specified lab values.
  • Patients who are unable to take oral medication.
  • Unlikely to survive more than 2 weeks.
  • Renal impairment.

Concurrent Medication:

Excluded:

  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
  • Excluded within 4 weeks of study entry:
  • Greater than 1 mg/kg/wk amphotericin B.
  • Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

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 defined by specified lab values.
  • Patients who are unable to take oral medication.
  • Life expectancy of < 2 weeks.
  • Any condition that may impair absorption of oral medication.

Prior Medication:

Excluded:

  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
  • Excluded within 4 weeks of study entry:
  • Greater than 1 mg/kg/wk amphotericin B.

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 NCT00002076
Other Study ID Numbers  ICMJE 012J
056-162
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