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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR ISONIAZID; PYRAZINAMIDE; RIFAMPIN

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Clinical Trials for Isoniazid; Pyrazinamide; Rifampin

Trial ID Title Status Sponsor Phase Summary
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.
NCT00000950 Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.
NCT00001033 The Treatment of Tuberculosis in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resistance in these two regimens. ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the treatment of pulmonary TB in HIV-infected patients who are either from areas with known high rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be susceptible to commonly used anti-TB drugs. PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established. ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined.
NCT00023374 TBTC Study 24: Intermittent Treatment of TB With Isoniazid Resistance or Intolerance Completed VA Office of Research and Development N/A This study is a prospective, open-label, nonrandomized trial using a largely-intermittent, six-month tuberculosis treatment regimen among patients who will not receive isoniazid due to the presence of initial isoniazid resistance or intolerance. Subjects are enrolled after resistance or intolerance to isoniazid has been documented, and are treated for a total of six months (nine months if baseline chest x-ray shows cavitation and 2-month sputum culture is positive) with twice weekly or thrice weekly rifampin, ethambutol, and pyrazinamide.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Isoniazid; Pyrazinamide; Rifampin

Condition Name

Condition Name for Isoniazid; Pyrazinamide; Rifampin
Intervention Trials
Tuberculosis 20
HIV Infections 7
Tuberculosis, Pulmonary 3
Pulmonary Tuberculosis 2
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Condition MeSH

Condition MeSH for Isoniazid; Pyrazinamide; Rifampin
Intervention Trials
Tuberculosis 30
Tuberculosis, Pulmonary 8
HIV Infections 7
Infection 6
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Clinical Trial Locations for Isoniazid; Pyrazinamide; Rifampin

Trials by Country

Trials by Country for Isoniazid; Pyrazinamide; Rifampin
Location Trials
United States 114
Canada 15
South Africa 14
Brazil 10
Uganda 5
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Trials by US State

Trials by US State for Isoniazid; Pyrazinamide; Rifampin
Location Trials
California 10
New York 9
Maryland 8
New Jersey 7
Illinois 7
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Clinical Trial Progress for Isoniazid; Pyrazinamide; Rifampin

Clinical Trial Phase

Clinical Trial Phase for Isoniazid; Pyrazinamide; Rifampin
Clinical Trial Phase Trials
Phase 4 6
Phase 3 8
Phase 2 11
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Clinical Trial Status

Clinical Trial Status for Isoniazid; Pyrazinamide; Rifampin
Clinical Trial Phase Trials
Completed 17
Recruiting 5
Unknown status 3
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Clinical Trial Sponsors for Isoniazid; Pyrazinamide; Rifampin

Sponsor Name

Sponsor Name for Isoniazid; Pyrazinamide; Rifampin
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 7
Centers for Disease Control and Prevention 7
Johns Hopkins University 4
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Sponsor Type

Sponsor Type for Isoniazid; Pyrazinamide; Rifampin
Sponsor Trials
Other 93
U.S. Fed 9
NIH 8
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