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

Completed · Not applicable

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

To evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS. Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.

Key facts

Study ID

NCT00002113

Run by

Pfizer

People needed

64

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCI Med Ctr — Orange, California, United States
• UCSD Med Ctr - Owen Clinic — San Diego, California, United States

Full record on ClinicalTrials.gov

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