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Cantor Fitzgerald
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Colorcon
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Cerilliant
Accenture
Moodys
Mallinckrodt

Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ISONIAZID

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Clinical Trials for Isoniazid

Trial ID Title Status Sponsor Phase Summary
NCT00000588 Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload.
NCT00000588 Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone Completed Case Western Reserve University Phase 2 To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload.
NCT00000636 Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
NCT00000638 Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection Completed Hoechst Marion Roussel N/A To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000638 Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection Completed Lederle Laboratories N/A To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000638 Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Isoniazid

Condition Name

Condition Name for Isoniazid
Intervention Trials
Tuberculosis 88
HIV Infections 25
Tuberculosis, Pulmonary 12
Pulmonary Tuberculosis 10
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Condition MeSH

Condition MeSH for Isoniazid
Intervention Trials
Tuberculosis 138
Tuberculosis, Pulmonary 35
HIV Infections 31
Infection 19
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Clinical Trial Locations for Isoniazid

Trials by Country

Trials by Country for Isoniazid
Location Trials
United States 267
Canada 44
South Africa 39
Brazil 26
China 18
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Trials by US State

Trials by US State for Isoniazid
Location Trials
California 24
New York 22
Texas 19
Maryland 18
Illinois 18
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Clinical Trial Progress for Isoniazid

Clinical Trial Phase

Clinical Trial Phase for Isoniazid
Clinical Trial Phase Trials
Phase 4 30
Phase 3 41
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Isoniazid
Clinical Trial Phase Trials
Completed 73
Recruiting 24
Not yet recruiting 23
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Clinical Trial Sponsors for Isoniazid

Sponsor Name

Sponsor Name for Isoniazid
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 27
Centers for Disease Control and Prevention 20
Johns Hopkins University 10
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Sponsor Type

Sponsor Type for Isoniazid
Sponsor Trials
Other 304
NIH 37
U.S. Fed 35
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Fuji
Medtronic
Merck
US Army
Farmers Insurance
McKinsey
Boehringer Ingelheim
Baxter

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