Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000636
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Prophylaxis 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 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
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
Detailed Description:
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
After baseline screening patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months then every three months for the first year there are additional clinic visits for INH patients Patients are then evaluated every six months One group of patients takes INH plus vitamin B6 for 12 months The other group of patients takes 1 of 2 doses of rifampin depending on patients weight plus pyrazinamide in 3-4 divided doses for 60 days
After baseline screening patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months then every three months for the first year there are additional clinic visits for INH patients Patients are then evaluated every six months One group of patients takes INH plus vitamin B6 for 12 months The other group of patients takes 1 of 2 doses of rifampin depending on patients weight plus pyrazinamide in 3-4 divided doses for 60 days
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 |
|---|---|---|---|
| 11556 | REGISTRY | DAIDS ES Registry Number | None |
| TBPPD | None | None | None |
| ACTG 177 | None | None | None |