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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002076

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Fluconazole	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Summitt Med Ctr / San Francisco Gen Hosp	Oakland	California	United States	94609
2	Cornell Univ Med Ctr	New York	New York	United States	10021
3	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania	United States	19107