Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

NCT00002010 | Completed

• 2 other identifiers: 012P056-170
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

The study is intended to examine the efficacy of fluconazole for the treatment of coccidioidal meningitis in patients with new onset of infection, relapse of previous infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined.

Conditions

Meningitis; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Meningitis; Fluconazole; Coccidioidin; Acquired Immunodeficiency Syndrome; Coccidioidomycosis

Interventions

Fluconazole DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Immunosuppressive therapy including corticosteroids and/or cytotoxic agents.
• Antiviral therapy (e.g., zidovudine (AZT)).
• Prophylaxis for Pneumocystis carinii pneumonia (PCP).
• Any exceptions to use of concomitant medications must be approved by Pfizer Central Research prior to study entry.
• Concurrent Treatment:
• Allowed:
• Radiation therapy for mucocutaneous Kaposi's sarcoma.
• Patients must:
• Be clinically judged to be in need of treatment for coccidioidal meningitis.
• Have \> 1 week life expectancy.
• Allowed:
• Immunocompromised patients.
• Patients with renal disease will have the dose of fluconazole adjusted and serum levels may be monitored.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Current antifungal infection that is responding to another agent. Findings of improvement include one of the following, while on other therapy (without subsequent relapse of the item):
• CSF culture conversion from positive to negative.
• CSF antibody titer decrease of at least one dilution.
• Improvement in signs and symptoms of meningitis.
• Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
• Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.
• Concurrent Medication:
• Excluded:
• Barbiturates.
• Phenytoin.
• Oral hypoglycemics.
• Coumadin type anticoagulants.
• Other systemic or intrathecal antifungal therapy.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Tucson Veterans Administration Med Ctr

Tucson, Arizona, 85724, United States

Location

HIV Research Group

San Diego, California, 92102, United States

Location

Audie L Murphy Veterans Administration Hosp

San Antonio, Texas, 78284, United States

Location

MeSH Terms

Conditions

Meningitis; HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome; Coccidioidomycosis

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases; Mycoses; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1992-02

Locations

US (3)