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

• ClinicalTrials.gov Identifier: NCT00002076
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Pfizer
• Information provided by: NIH AIDS Clinical Trials Information Service

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, California

Summitt Med Ctr / San Francisco Gen Hosp

Oakland, California, United States, 94609

United States, New York

Cornell Univ Med Ctr

New York, New York, United States, 10021

United States, Pennsylvania

Buckley Braffman Stern Med Associates

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Pfizer

More Information

• ClinicalTrials.gov Identifier: NCT00002076
• Other Study ID Numbers: 012J; 056-162
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Last Verified: February 1990

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections; Meningitis; Cryptococcosis; Fluconazole; Administration, Oral; Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

Meningococcal Infections; Meningitis, Cryptococcal; Meningitis; Central Nervous System Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Meningitis, Fungal; Central Nervous System Fungal Infections; Mycoses; Cryptococcosis; Central Nervous System Infections; Fluconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors