Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000638
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Preventive Treatment Against Tuberculosis TB in Patients With Human Immunodeficiency Virus HIV Infection and Confirmed Latent Tuberculous Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Prophylaxis Against Tuberculosis TB in Patients With Human Immunodeficiency Virus HIV Infection and Confirmed Latent Tuberculous Infection
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11152 | REGISTRY | DAIDS ES Registry Number | None |
| CPCRA 004 | None | None | None |
| TBPPD | None | None | None |