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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000776 |
To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with cryptococcal meningitis and intracranial hypertension.
In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.
Condition | Intervention | Phase |
Meningitis, Cryptococcal HIV Infections |
Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B Drug: Dexamethasone |
Phase II |
MedlinePlus related topics: | AIDS Meningitis |
Drug Information available for: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Amphotericin B Fluconazole Flucytosine |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | Dexamethasone in Cryptococcal Meningitis |
Estimated Enrollment: | 36 |
In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.
Patients are randomized to receive dexamethasone or placebo every 6 hours for 72 hours (days 1 through 3). Additionally, standard antifungal therapy with amphotericin B and flucytosine is given for 2 weeks, followed by fluconazole for 8 weeks. Lumbar punctures will be performed daily on days 1 through 3, on days 7 and 14, and at week 10.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 7 days prior to study entry:
United States, Alabama | |||||
Univ of Alabama at Birmingham | |||||
Birmingham, Alabama, United States, 35294 | |||||
United States, District of Columbia | |||||
Georgetown Univ Med Ctr | |||||
Washington, District of Columbia, United States, 20007 | |||||
United States, Florida | |||||
Univ of Miami School of Medicine | |||||
Miami, Florida, United States, 331361013 | |||||
United States, Illinois | |||||
Northwestern Univ Med School | |||||
Chicago, Illinois, United States, 60611 | |||||
Cook County Hosp | |||||
Chicago, Illinois, United States, 60612 | |||||
United States, New York | |||||
Mount Sinai Med Ctr | |||||
New York, New York, United States, 10029 | |||||
Jack Weiler Hosp / Bronx Municipal Hosp | |||||
Bronx, New York, United States, 10465 | |||||
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |||||
Bronx, New York, United States, 10461 | |||||
Bronx Veterans Administration / Mount Sinai Hosp | |||||
Bronx, New York, United States, 10468 | |||||
SUNY / Erie County Med Ctr at Buffalo | |||||
Buffalo, New York, United States, 14215 | |||||
Beth Israel Med Ctr | |||||
New York, New York, United States, 10003 | |||||
SUNY / Health Sciences Ctr at Brooklyn | |||||
Brooklyn, New York, United States, 112032098 | |||||
United States, Ohio | |||||
Ohio State Univ Hosp Clinic | |||||
Columbus, Ohio, United States, 432101228 | |||||
Puerto Rico | |||||
Univ of Puerto Rico | |||||
San Juan, Puerto Rico, 009365067 |
Study Chair: | J Jacobson |
Click here for more information about Fluconazole 
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Click here for more information about Amphotericin B 
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Study ID Numbers: | ACTG 202 |
First Received: | November 2, 1999 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00000776 |
Health Authority: | United States: Federal Government |
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