Clinical trial NCT00002305: A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
Official title: Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meningitis, Cryptococcal
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Meningitis
Cryptococcosis
Drug Therapy, Combination
Fluconazole
Flucytosine
Acquired Immunodeficiency Syndrome
Amphotericin B
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.


Eligibility criteria: 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.

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