A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
2 other identifiers
interventional
64
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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:
- +2 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCI Med Ctr
Orange, California, 92668, United States
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681, United States
Related Publications (1)
Larsen RA, Bozzette SA, Jones BE, Haghighat D, Leal MA, Forthal D, Bauer M, Tilles JG, McCutchan JA, Leedom JM. Fluconazole combined with flucytosine for treatment of cryptococcal meningitis in patients with AIDS. Clin Infect Dis. 1994 Oct;19(4):741-5. doi: 10.1093/clinids/19.4.741.
PMID: 7803641BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04