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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

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Clinical Trials for Fluconazole In Sodium Chloride 0.9%

Trial ID Title Status Sponsor Phase 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 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 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 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 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.
NCT00000676 Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) Completed Pfizer Phase 3 To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Fluconazole In Sodium Chloride 0.9%

Condition Name

Condition Name for Fluconazole In Sodium Chloride 0.9%
Intervention Trials
HIV Infections 42
Candidiasis 18
Meningitis, Cryptococcal 16
Mycoses 15
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Condition MeSH

Condition MeSH for Fluconazole In Sodium Chloride 0.9%
Intervention Trials
Candidiasis 52
HIV Infections 45
Mycoses 33
Infection 27
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Clinical Trial Locations for Fluconazole In Sodium Chloride 0.9%

Trials by Country

Trials by Country for Fluconazole In Sodium Chloride 0.9%
Location Trials
United States 628
Canada 20
China 13
Spain 10
Belgium 9
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Trials by US State

Trials by US State for Fluconazole In Sodium Chloride 0.9%
Location Trials
California 48
Texas 45
New York 41
Florida 36
Pennsylvania 33
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Clinical Trial Progress for Fluconazole In Sodium Chloride 0.9%

Clinical Trial Phase

Clinical Trial Phase for Fluconazole In Sodium Chloride 0.9%
Clinical Trial Phase Trials
Phase 4 25
Phase 3 44
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Fluconazole In Sodium Chloride 0.9%
Clinical Trial Phase Trials
Completed 128
Recruiting 29
Terminated 11
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Clinical Trial Sponsors for Fluconazole In Sodium Chloride 0.9%

Sponsor Name

Sponsor Name for Fluconazole In Sodium Chloride 0.9%
Sponsor Trials
Pfizer 37
National Institute of Allergy and Infectious Diseases (NIAID) 25
Merck Sharp & Dohme Corp. 7
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Sponsor Type

Sponsor Type for Fluconazole In Sodium Chloride 0.9%
Sponsor Trials
Other 152
Industry 114
NIH 43
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