A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis

HIV Infections Clinical Trial

Official title:

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002305
• Other study ID #: 012F
• Secondary ID: 056-159
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1989
• 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 compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Immunosuppressant therapy.

• Antiviral therapy such as zidovudine.

• Prophylaxis for Pneumocystis carinii pneumonia.

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.

• Relapse after prior therapy.

• 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:

• Immunosuppressant therapy.

• Antiviral therapy (such as zidovudine).

• Prophylaxis for Pneumocystis carinii pneumonia.

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.

• Comatose.

• Unlikely to survive more than 2 weeks.

• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Medication:

Excluded:

• Coumadin-type anticoagulants.

• Oral hypoglycemics.

• Barbiturates.

• Phenytoin.

• Immunostimulants.

• Investigational drugs or approved (licensed) drugs for investigational indications.

• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

• Excluded within 4 weeks of study entry:

• Greater than 1 mg/kg/wk amphotericin B.

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, azoles, or amphotericin B.

• Moderate or severe liver disease.

• Comatose.

• Unlikely to survive more than 2 weeks.

Prior Medication:

Excluded:

• Coumadin-type anticoagulants.

• Oral hypoglycemics.

• Barbiturates.

• Phenytoin.

• Immunostimulants.

• Investigational drugs or approved (licensed) drugs for investigational indications.

• 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:
• Flucytosine

• Fluconazole

• Amphotericin B

Locations

Country	Name	City	State
Canada	Saint Michael's Hosp	Toronto	Ontario
United States	Albany Med College / AIDS Treatment Ctr	Albany	New York
United States	Ann Arbor Veterans Administration Med Ctr	Ann Arbor	Michigan
United States	Emory Univ School of Medicine	Atlanta	Georgia
United States	Med College of Georgia	Augusta	Georgia
United States	Loch Raven Veterans Hosp	Baltimore	Maryland
United States	Univ of Maryland / Inst of Human Virology	Baltimore	Maryland
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	New England Med Ctr	Boston	Massachusetts
United States	Univ Hosp	Boston	Massachusetts
United States	Bronx Veterans Administration / Mount Sinai Hosp	Bronx	New York
United States	Montefiore Med Ctr / Bronx Municipal Hosp	Bronx	New York
United States	Univ of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Cincinnati Veterans Adm Med Ctr / Univ Hosp	Cincinnati	Ohio
United States	Ohio State Univ Hosp	Columbus	Ohio
United States	Dr Daniel Barbaro	Dallas	Texas
United States	DeKalb Gen Hosp	Decatur	Georgia
United States	Harper Hosp	Detroit	Michigan
United States	Henry Ford Hosp	Detroit	Michigan
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Jewish Hosp Ctr Affiliation	Jamaica	New York
United States	United States Air Force Med Ctr	Lackland Air Force Base	Texas
United States	UCLA CARE Ctr	Los Angeles	California
United States	Univ of Tennessee	Memphis	Tennessee
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Louisiana State Univ School of Medicine	New Orleans	Louisiana
United States	Tulane Univ School of Medicine	New Orleans	Louisiana
United States	Chelsea Village Med Ctr	New York	New York
United States	Columbia Univ	New York	New York
United States	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York
United States	Mem Sloan - Kettering Cancer Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	Dr Michael Bach	Portland	Maine
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	Dr Martin Mass	San Francisco	California
United States	Dr Shelly Gordon	San Francisco	California
United States	CHG-118 Group Health / Cooperative of Puget Sound	Seattle	Washington
United States	Dr Paul Rothman	Sherman Oaks	California
United States	Washington Univ School of Medicine	St. Louis	Missouri
United States	Univ of South Florida	Tampa	Florida
United States	Tucson Veterans Administration Med Ctr	Tucson	Arizona
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Christiana Hosp / Med Ctr of Delaware	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,