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Sponsors and Collaborators: |
Hoechst Marion Roussel Lederle Laboratories National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000638 |
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.
Condition | Intervention |
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HIV Infections Tuberculosis |
Drug: Isoniazid Drug: Pyrazinamide Drug: Pyridoxine hydrochloride Drug: Rifampin |
Study Type: | Interventional |
Study Design: | Prevention, Parallel Assignment, Safety Study |
Official Title: | Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection |
Estimated Enrollment: | 2000 |
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.
Patients are chosen by a random selection process to either the INH or the rifampin / pyrazinamide arm of the dose. Patients on the INH arm receive INH plus vitamin B6 (pyridoxine hydrochloride ) daily for 12 months. Patients on the other arm receive rifampin plus pyrazinamide for 60 days. Dosage of rifampin and pyrazinamide depends on weight of patient.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Patients may not have the following prior conditions:
Study Chair: | Chaisson R |
Study ID Numbers: | ACTG 177, CPCRA 004, TB/PPD+ |
Study First Received: | November 2, 1999 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00000638 |
Health Authority: | Unspecified |
Tuberculosis Isoniazid Mycobacterium tuberculosis Pyrazinamide Pyridoxine Rifampin |
AIDS-Related Opportunistic Infections Drug Therapy, Combination Acquired Immunodeficiency Syndrome Antitubercular Agents AIDS-Related Complex |
Bacterial Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome AIDS-Related Complex Pyrazinamide Vitamin B 6 Immunologic Deficiency Syndromes Virus Diseases Rifampin |
Gram-Positive Bacterial Infections HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Mycobacterium Infections Pyridoxine Tuberculosis Retroviridae Infections Isoniazid |
Antimetabolites Communicable Diseases Anti-Infective Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Anti-Bacterial Agents Therapeutic Uses Vitamins Micronutrients Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Vitamin B Complex Immune System Diseases Antilipemic Agents Growth Substances Enzyme Inhibitors Pharmacologic Actions Actinomycetales Infections Antibiotics, Antitubercular Lentivirus Infections Antitubercular Agents Fatty Acid Synthesis Inhibitors Leprostatic Agents |