Dexamethasone in Cryptococcal Meningitis

HIV Infections Clinical Trial

Official title:

Dexamethasone in Cryptococcal Meningitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000776
• Other study ID #: ACTG 202
• Secondary ID: 11178
• Status: Completed
• Phase: Phase 2
• Est. completion date: September 1996

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Flucytosine

• Fluconazole

• Amphotericin B

• Dexamethasone

Locations

Country	Name	City	State
Puerto Rico	Univ of Puerto Rico	San Juan
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Bronx Municipal Hosp Ctr/Jacobi Med Ctr	Bronx	New York
United States	Bronx Veterans Administration / Mount Sinai Hosp	Bronx	New York
United States	Jack Weiler Hosp / Bronx Municipal Hosp	Bronx	New York
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	Cook County Hosp	Chicago	Illinois
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Ohio State Univ Hosp Clinic	Columbus	Ohio
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Beth Israel Med Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico,