Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402454
Status:
COMPLETED
Last Update Posted:
2007-01-11
First Post:
2006-11-18
Brief Title:
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis
Sponsor:
Sociedad Andaluza de Enfermedades Infecciosas
Organization:
Sociedad Andaluza de Enfermedades Infecciosas
Study Overview
Official Title:
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis
Status:
COMPLETED
Status Verified Date:
2006-11
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 adherence and safety of three regimens of chemoprophylaxis for tuberculosis TB in HIV-infected patients with positive tuberculin skin test
Detailed Description:
DESINGS We performed a randomised comparative and open clinical assay carried out in 316 HIV-infected patients The patients were randomly assigned to one of three regimens 108 to isoniazid for six months 6H 103 to rifampin and isoniazid for three months 3RH and 105 to pyrazinamide and rifampin for two months 2RZ
RESULTS The TB rates cases per 100 personsyear in the three treatment groups were 34 in 6H 45 in 3RH and 19 in 2RZ The relative risk for TB with 6H as compared with 2RZ was 176 and with 3RH 234 Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 97 were withdrawn due to adverse side-effects Seven patients were withdraw due to hepatotoxicity 5 in 6H 2 in 3RH and 0 in 2RZ No appreciable differences were found among the three regimens
CONCLUSION In our study the 2RZ regimen was as safe as the 6H and 3RH regimens We have nor observed a higher incidence of hepatotoxicity in patients who received 2RZ
RESULTS The TB rates cases per 100 personsyear in the three treatment groups were 34 in 6H 45 in 3RH and 19 in 2RZ The relative risk for TB with 6H as compared with 2RZ was 176 and with 3RH 234 Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 97 were withdrawn due to adverse side-effects Seven patients were withdraw due to hepatotoxicity 5 in 6H 2 in 3RH and 0 in 2RZ No appreciable differences were found among the three regimens
CONCLUSION In our study the 2RZ regimen was as safe as the 6H and 3RH regimens We have nor observed a higher incidence of hepatotoxicity in patients who received 2RZ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FIS 940071B | None | None | None |