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Home > "D" Clinical Trials Conditions > Dexamethasone in Cryptococcal Meningitis  Dexamethasone in Cryptococcal Meningitis
Dexamethasone in Cryptococcal Meningitis
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: 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 Co-existing Condition: 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.
Total Enrollment: 36
Location and Contact Information:
Overall Study Official:
JJacobson, Study Chair,
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Beth Israel Med Ctr
New York City, New York, 10003
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Additional Information:
Study ID Numbers: ACTG 202;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000776
Other Meningitis, Cryptococcal Studies:
1. SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
2. A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
3. An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
4. Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
5. Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis
Related Studies:
Other Meningitis, Cryptococcal Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Dexamethasone in Cryptococcal Meningitis
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