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Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002040
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Official Title  ICMJE Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Brief Summary To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS patients. Both newly diagnosed and relapsed patients are eligible. The effectiveness of maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: None (Open Label)
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:

  • Antivirals 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.

  • Patient's treatment status must be one of the following:
  • No prior systemic antifungal therapy for cryptococcosis.
  • Relapse after prior therapy. The success of prior therapy must have been documented by negative 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 the study.

Prior Medication:

Allowed:

  • Antivirals such as zidovudine (AZT). 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.
  • A history of allergy to or intolerance of imidazoles or azoles.
  • Moderate or severe liver disease defined by specified lab values.
  • Life expectancy of < 2 weeks.

Concurrent Medication:

Excluded:

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

Concurrent Treatment:

Excluded:

  • Lymphocyte replacement.

Patients with the following are excluded:

  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • A history of allergy to or intolerance of imidazoles or azoles.
  • Moderate or severe liver disease defined by specified lab values.
  • Life expectancy of < 2 weeks.

Prior Medication:

Excluded:

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

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 NCT00002040
Other Study ID Numbers  ICMJE 012L
056-164A
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