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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002076
• Other study ID #: 012J
• Secondary ID: 056-162
• 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 treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.

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:

• 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Fluconazole

Locations

Country	Name	City	State
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,