Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
1996-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Flucytosine
Fluconazole
Amphotericin B
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Aerosolized pentamidine or systemic chemoprophylaxis for PCP.
* Preventive therapy for steroid-associated ulcers and any other therapies required to manage steroid toxicity (e.g., insulin).
Patients must have:
* Documented initial episode or relapse of acute cryptococcal meningitis. (NOTE: Patients must be untreated for this episode except for administration of a test dose of 1 g or less amphotericin B.)
* Acute cryptococcal meningitis with cerebrospinal fluid opening pressure \>= 250 mm H2O prior to receipt of antifungal therapy for this episode.
* Documented HIV infection OR a diagnosis of AIDS based on a documented AIDS-defining opportunistic infection.
* Ability to begin therapy within 8 hours after the pre-entry lumbar puncture.
* Consent of parent or guardian if less than 18 years of age.
NOTE:
* Comatose patients eligible provided informed consent can be provided by guardian or next of kin.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Concurrent CNS disease such as another infection or neoplasm that would interfere with assessment of response.
* Prison incarceration.
Concurrent Medication:
Excluded:
* Acetazolamide, mannitol, urea preparations, and other corticosteroids during the first 72 hours of the study.
* Treatment or prophylaxis with other systemic antifungal agents at any time.
* Antiretroviral therapy during the first 72 hours of the study.
Prior Medication:
Excluded within 7 days prior to study entry:
* Corticosteroids, mannitol, urea preparations, acetazolamide, or more than 24 hours of phenytoin.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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J Jacobson
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States
Univ of Puerto Rico
San Juan, , Puerto Rico
Countries
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Other Identifiers
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11178
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 202
Identifier Type: -
Identifier Source: org_study_id