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Generated: September 17, 2019

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CLINICAL TRIALS PROFILE FOR ITRACONAZOLE

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Clinical Trials for Itraconazole

Trial ID Title Status Sponsor Phase 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 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.
NCT00000975 A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed Janssen Pharmaceuticals Phase 2 To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
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Clinical Trial Conditions for Itraconazole

Condition Name

Condition Name for Itraconazole
Intervention Trials
Healthy 42
Healthy Volunteers 14
HIV Infections 11
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Condition MeSH

Condition MeSH for Itraconazole
Intervention Trials
Mycoses 15
Infection 15
HIV Infections 13
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Clinical Trial Locations for Itraconazole

Trials by Country

Trials by Country for Itraconazole
Location Trials
United States 222
United Kingdom 20
Canada 16
Germany 16
Belgium 13
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Trials by US State

Trials by US State for Itraconazole
Location Trials
Texas 28
California 21
Florida 13
Maryland 13
Missouri 12
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Clinical Trial Progress for Itraconazole

Clinical Trial Phase

Clinical Trial Phase for Itraconazole
Clinical Trial Phase Trials
Phase 4 27
Phase 3 16
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Itraconazole
Clinical Trial Phase Trials
Completed 120
Recruiting 53
Not yet recruiting 32
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Clinical Trial Sponsors for Itraconazole

Sponsor Name

Sponsor Name for Itraconazole
Sponsor Trials
Boehringer Ingelheim 14
Pfizer 11
National Institute of Allergy and Infectious Diseases (NIAID) 9
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Sponsor Type

Sponsor Type for Itraconazole
Sponsor Trials
Industry 160
Other 114
NIH 14
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