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A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

Last updated on March 15, 2019

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Study Location
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cryptococcal Meningitis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Concurrent Medication:

Allowed:

- Antiviral therapy (AZT, DHPG).

- Prophylaxis for Pneumocystis carinii pneumonia.

- Treatment for intercurrent opportunistic infection.

Concurrent Treatment:

Allowed:

- Radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must have:

- AIDS.

- Evidence of Cryptococcal neoformans in culture or lumbar CSF OR clinical and CSF
findings compatible with cryptococcal meningitis.

- No evidence of acute or chronic meningitis of any etiology other than cryptococcosis.

- Life expectancy of at least 2 weeks.

Prior Medication:

Allowed:

- Prior antiviral therapy (AZT, DHPG).

- Prophylaxis for Pneumocystis carinii pneumonia.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Relapsing on maintenance triazole therapy for cryptococcal meningitis.

- Unable to take oral medication.

Concurrent Medication:

Excluded:

- Concomitant use of any antifungal agent other than study drug.

Patients with the following prior conditions are excluded:

History of allergy to or intolerance of imidazoles, azoles, or flucytosine.

Prior Medication:

Excluded:

- More than 1 mg/kg amphotericin B.

- Systemic antifungal agents within 7 days prior to study entry.

NCT00002113
Pfizer
Completed
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

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