Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
NCT00002040
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
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.
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.
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| 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 |
| ||
| 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:
Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Concurrent Medication: 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 | 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 | |||