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Dexamethasone in Cryptococcal Meningitis
This study has been completed.
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
  Purpose

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
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: Dexamethasone in Cryptococcal Meningitis

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 36
Detailed Description:

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000776

Locations
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
Sponsors and Collaborators
Investigators
Study Chair: J Jacobson
  More Information

Click here for more information about Fluconazole  This link exits the ClinicalTrials.gov site
Click here for more information about Amphotericin B  This link exits the ClinicalTrials.gov site

Study ID Numbers: ACTG 202
Study First Received: November 2, 1999
Last Updated: August 5, 2008
ClinicalTrials.gov Identifier: NCT00000776  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Meningitis
Cryptococcosis
Dexamethasone
Drug Therapy, Combination
Fluconazole
Flucytosine
Acquired Immunodeficiency Syndrome
Amphotericin B
Brain Diseases

Study placed in the following topic categories:
Abelcet
Dexamethasone
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Clotrimazole
Miconazole
Flucytosine
Brain Diseases
Liposomal amphotericin B
Meningitis
Mycoses
AIDS-Related Opportunistic Infections
Meningitis, Cryptococcal
Retroviridae Infections
Dexamethasone acetate
Fluconazole
Amphotericin B
Meningitis, Fungal
Acquired Immunodeficiency Syndrome
Tioconazole
Central Nervous System Diseases
Immunologic Deficiency Syndromes
Virus Diseases
Central Nervous System Infections
HIV Infections
Sexually Transmitted Diseases
Cryptococcosis

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Infection
Hormones
Anti-Bacterial Agents
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides
Central Nervous System Fungal Infections
RNA Virus Infections
Antineoplastic Agents, Hormonal
Immune System Diseases
Nervous System Diseases
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lentivirus Infections
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009