NCT00002113

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (planned)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. Therapy continues until 8 weeks after the CSF becomes culture negative, up to a maximum of 26 weeks.

Conditions

• Meningitis, Cryptococcal
• HIV Infections

Interventions

Type	Name	Description
DRUG	Flucytosine
DRUG	Fluconazole

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

3 sites across 1 country: United States