A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningitis, Cryptococcal; HIV Infections
Intervention: Fluconazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
Summary
To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal
meningitis in patients who have had an unsatisfactory response to or have experienced
unacceptable toxicity with amphotericin B.
Clinical Details
Official title: Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B
Study design: Treatment
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer
Central Research, protocol #159.
- Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for
Cryptococcus neoformans.
- Written informed consent must be obtained for each patient, either from the patient
himself or from the patient's legal guardian.
- Each individual patient must be approved by Pfizer Central Research prior to study
entry.
Prior Medication:
Allowed:
- Immunosuppressant therapy.
- 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 or azoles.
- Moderate or severe liver disease.
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.
- Satisfactory response to amphotericin B and have received a total amphotericin B dose
of 15 mg/kg or more since CSF culture documentation of the current episode of acute
cryptococcal meningitis.
- Life expectancy of < 2 weeks.
Prior Medication:
Excluded:
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Univ of South Florida, Tampa, Florida 33612, United States
Med College of Georgia, Augusta, Georgia 30912, United States
Emory Univ School of Medicine, Atlanta, Georgia 30303, United States
Univ Hosp, Boston, Massachusetts 02118, United States
Ann Arbor Veterans Administration Med Ctr, Ann Arbor, Michigan 48105, United States
Washington Univ School of Medicine, St. Louis, Missouri 63108, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States
Bronx Veterans Administration / Mount Sinai Hosp, Bronx, New York 10468, United States
Cincinnati Veterans Adm Med Ctr / Univ Hosp, Cincinnati, Ohio 452670405, United States
United States Air Force Med Ctr, Lackland Air Force Base, Texas 782365300, United States
Southwest Texas Methodist Hosp, San Antonio, Texas 78229, United States
Univ TX San Antonio Health Science Ctr, San Antonio, Texas 78284, United States
Additional Information
Last updated: June 23, 2005
|
