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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002076
Other study ID # 012J
Secondary ID 056-162
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 evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.


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:

- Antiviral therapy such as zidovudine.

- Prophylaxis for Pneumocystis carinii pneumonia.

- Aerosolized 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.

- 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:

- Antiviral therapy such as zidovudine.

- Prophylaxis for Pneumocystis carinii pneumonia.

- Aerosolized 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 defined by specified lab values.

- Patients who are unable to take oral medication.

- Unlikely to survive more than 2 weeks.

- Renal impairment.

Concurrent Medication:

Excluded:

- Coumarin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.

- Excluded within 4 weeks of study entry:

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

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

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 or azoles.

- Moderate or severe liver disease defined by specified lab values.

- Patients who are unable to take oral medication.

- Life expectancy of < 2 weeks.

- Any condition that may impair absorption of oral medication.

Prior Medication:

Excluded:

- Coumarin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.

- Excluded within 4 weeks of study entry:

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

Prior Treatment:

Excluded:

- Lymphocyte replacement.

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Fluconazole


Locations

Country Name City State
United States Cornell Univ Med Ctr New York New York
United States Summitt Med Ctr / San Francisco Gen Hosp Oakland California
United States Buckley Braffman Stern Med Associates Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

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