A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
NCT00002306
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
Adult Trials: 18+ Years
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.
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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| 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 |
| ||
| 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:
Concurrent Treatment: Allowed:
Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.
Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Concurrent Treatment: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
Prior Treatment: Excluded:
| ||
| Sex/Gender ICMJE |
| ||
| 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 | |||