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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002040
• Other study ID #: 012L
• Secondary ID: 056-164A
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Fluconazole

Locations

Country	Name	City	State
United States	SUNY / Health Sciences Ctr at Brooklyn	Brooklyn	New York
United States	Cook County Hosp	Chicago	Illinois
United States	Cornell Univ Med Ctr	New York	New York
United States	Summitt Med Ctr / San Francisco Gen Hosp	Oakland	California
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,