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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002075
Other study ID # 012G
Secondary ID 056-159A
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date September 1989
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 18 Years and older
Eligibility Inclusion Criteria

Concurrent Medication:

Allowed:

- Immunosuppressant therapy.

- Antiviral such as zidovudine.

- Radiation therapy for mucocutaneous Kaposi's sarcoma.

- Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.

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.

- Antivirals such as zidovudine (AZT).

- Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.

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.

- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Medication:

Excluded:

- Coumadin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

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

- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

- Excluded within 4 weeks of study entry:

- Received more than 1 mg/kg/wk amphotericin B.

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:

- Coumadin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

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

- Excluded within 4 weeks of study entry:

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

Prior Treatment:

Excluded:

- Lymphocyte replacement.

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Flucytosine

Fluconazole

Amphotericin B


Locations

Country Name City State
United States Dr Robert Larsen Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

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