CLINICAL TRIALS PROFILE FOR FLUCONAZOLE

505(b)(2) Clinical Trials for fluconazole

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni Bucharest	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Universitaire Ziekenhuizen Leuven	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.

All Clinical Trials for fluconazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000627 ↗	Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome	Completed	Pfizer	N/A	1969-12-31	To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
NCT00000627 ↗	Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
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.

Clinical Trial Conditions for fluconazole

Condition Name

Condition Name for fluconazole
Intervention	Trials
HIV Infections	42
Candidiasis	21
Mycoses	19

Condition MeSH

Condition MeSH for fluconazole
Intervention	Trials
Candidiasis	77
HIV Infections	45
Mycoses	44

Clinical Trial Locations for fluconazole

Trials by Country

Trials by Country for fluconazole
Location	Trials
United States	766
China	33
Canada	28
Spain	18
Belgium	15

Trials by US State

Trials by US State for fluconazole
Location	Trials
California	57
Texas	53
Florida	46
New York	45
Pennsylvania	39

Clinical Trial Progress for fluconazole

Clinical Trial Phase

Clinical Trial Phase for fluconazole
Clinical Trial Phase	Trials
Phase 4	32
Phase 3	57
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for fluconazole
Clinical Trial Phase	Trials
Completed	183
Unknown status	21
Recruiting	20

Clinical Trial Sponsors for fluconazole

Sponsor Name

Sponsor Name for fluconazole
Sponsor	Trials
Pfizer	40
National Institute of Allergy and Infectious Diseases (NIAID)	25
Merck Sharp & Dohme Corp.	7

Sponsor Type

Sponsor Type for fluconazole
Sponsor	Trials
Other	212
Industry	161
NIH	46