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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002068
Other study ID # 012H
Secondary ID 056-159B
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date February 1990
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria

Concurrent Medication:

Allowed:

- Immunosuppressant therapy.

- Antiviral therapy such as zidovudine.

- Prophylaxis for Pneumocystis carinii pneumonia.

Concurrent Treatment:

Allowed:

- Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

- No prior systemic antifungal therapy for cryptococcosis.

- Relapse after prior therapy.

- Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.

Prior Medication:

Allowed:

- Immunosuppressant therapy.

- Antiviral therapy such as zidovudine.

- Prophylaxis for Pneumocystis carinii pneumonia.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.

- History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.

- Moderate or severe liver disease.

- Comatose.

- Unlikely to survive more than 2 weeks.

Concurrent Medication:

Excluded within 4 weeks of study entry:

- Greater than 1 mg/kg/wk amphotericin B.

- Coumadin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drugs or approved (licensed) drugs for investigational indications.

Concurrent Treatment:

Excluded:

- Lymphocyte replacement.

Patients with the following are excluded:

- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.

- History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.

- Moderate or severe liver disease.

- Comatose.

- Unlikely to survive more than 2 weeks.

Prior Medication:

Excluded within 4 weeks of study entry:

- Greater than 1 mg/kg/wk amphotericin B.

- Coumadin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drugs or approved (licensed) drugs for investigational indications.

Prior Treatment:

Excluded:

- Lymphocyte replacement.

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Fluconazole

Amphotericin B


Locations

Country Name City State
Canada Saint Michael's Hosp Toronto Ontario
United States Univ of Maryland / Inst of Human Virology Baltimore Maryland
United States Henry Ford Hosp Detroit Michigan
United States Univ of Tennessee Memphis Tennessee
United States Harlem AIDS Treatment Group / Harlem Hosp Ctr New York New York
United States Davies Med Ctr San Francisco California
United States Univ of South Florida Tampa Florida
United States Christiana Hosp / Med Ctr of Delaware Wilmington Delaware

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

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