Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Merck
McKesson
Express Scripts
Julphar
Cipla
McKinsey
Argus Health
Mallinckrodt

Generated: December 16, 2018

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR ITRACONAZOLE

« Back to Dashboard

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.
NCT00000975 A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) 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.
NCT00000992 A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 To test the effectiveness of itraconazole in preventing the recurrence of disseminated histoplasmosis in AIDS patients. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse.
NCT00001280 Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 This protocol describes a prospective, randomized study examining the safety and efficacy of Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease (CGD). CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals. As a result, affected patients are prone to recurrent, severe infections with bacterial and fungal organisms. Patients with CGD of 5 or more years of age without evidence of infection at the time of study entry will be eligible for enrollment. Patients will be randomized to receive itraconazole or placebo tablets daily, in a double blinded fashion. In addition to itraconazole, all patients will receive antimicrobial prophylaxis against bacterial infection, and may in addition receive gamma-interferon as prophylaxis against infection. Randomization of patients will be stratified among patients receiving or not receiving gamma interferon. The primary endpoint of the study will be the development of culture or histologically proved invasive fungal disease. Patients will be monitored every three months for evidence of drug toxicity. The anticipated accrual period will be approximately 36-48 months.
Trial ID Title Status Sponsor Phase Summary

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Clinical Trial Conditions for Itraconazole

Condition Name

Condition Name for Itraconazole
Intervention Trials
Healthy 34
Healthy Volunteers 11
HIV Infections 11
Neutropenia 8
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Itraconazole
Intervention Trials
Infection 15
Mycoses 14
HIV Infections 12
Neutropenia 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Itraconazole

Trials by Country

Trials by Country for Itraconazole
Location Trials
United States 215
United Kingdom 19
Canada 16
Germany 14
Netherlands 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Itraconazole
Location Trials
Texas 25
California 21
Maryland 12
Missouri 12
Florida 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for Itraconazole

Clinical Trial Phase

Clinical Trial Phase for Itraconazole
Clinical Trial Phase Trials
Phase 4 26
Phase 3 13
Phase 2/Phase 3 7
[disabled in preview] 145
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Itraconazole
Clinical Trial Phase Trials
Completed 120
Recruiting 45
Not yet recruiting 16
[disabled in preview] 22
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Itraconazole

Sponsor Name

Sponsor Name for Itraconazole
Sponsor Trials
Pfizer 10
Boehringer Ingelheim 10
National Institute of Allergy and Infectious Diseases (NIAID) 9
[disabled in preview] 20
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Itraconazole
Sponsor Trials
Industry 141
Other 103
NIH 14
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Julphar
Mallinckrodt
Teva
Chinese Patent Office
McKesson
US Army
Argus Health
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.