CLINICAL TRIALS PROFILE FOR FLUCYTOSINE

All Clinical Trials for flucytosine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000639 ↗	A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis	Completed	Washington University School of Medicine	N/A	1969-12-31	To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
NCT00000639 ↗	A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
NCT00000708 ↗	Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis in patients who have not been treated previously or who have relapsed after a previous successful treatment. Cryptococcal meningitis is an important cause of disease and death among patients with AIDS. Usually AMB is given either alone or with FLC to patients with this infection, but these treatments are not always effective and both have toxic effects. Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC.
NCT00000776 ↗	Dexamethasone in Cryptococcal Meningitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with cryptococcal meningitis and intracranial hypertension. In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.
NCT00002068 ↗	A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis	Completed	Pfizer	N/A	1969-12-31	To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
NCT00002075 ↗	Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis	Completed	Pfizer	N/A	1969-12-31	To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
NCT00002113 ↗	A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.	Completed	Pfizer	N/A	1969-12-31	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.

Clinical Trial Conditions for flucytosine

Condition Name

Condition Name for flucytosine
Intervention	Trials
HIV Infections	12
Cryptococcal Meningitis	10
Meningitis, Cryptococcal	9
Recurrent Adult Brain Tumor	2

Condition MeSH

Condition MeSH for flucytosine
Intervention	Trials
Meningitis, Cryptococcal	19
Meningitis	19
HIV Infections	12
Glioblastoma	5

Clinical Trial Locations for flucytosine

Trials by Country

Trials by Country for flucytosine
Location	Trials
United States	98
Canada	7
China	4
India	3
Kenya	3

Trials by US State

Trials by US State for flucytosine
Location	Trials
California	10
Texas	7
New York	7
Florida	7
Ohio	5

Clinical Trial Progress for flucytosine

Clinical Trial Phase

Clinical Trial Phase for flucytosine
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for flucytosine
Clinical Trial Phase	Trials
Completed	13
Unknown status	6
Terminated	4

Clinical Trial Sponsors for flucytosine

Sponsor Name

Sponsor Name for flucytosine
Sponsor	Trials
Tocagen Inc.	4
National Institute of Allergy and Infectious Diseases (NIAID)	4
Pfizer	4

Sponsor Type

Sponsor Type for flucytosine
Sponsor	Trials
Other	31
Industry	22
NIH	7