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During the Study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2HRZE/4HR | Experimental | Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months |
|
| 2HRLE/4HR | Active Comparator | Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months |
|
| 9HLE | Experimental | Isoniazid+ Levofloxacin+ Ethambutol for 9 months |
|
| 9RLE | Active Comparator | Rifampicin + Levofloxacin+ Ethambutol for 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2HRZE/4HR | Drug | Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen. | 6 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis, | 6 and 9 months | |
| Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Naveen Kumar, MD | Contact | 011-46300000 | naveenilbsdelhi@gmail.com | |
| Dr Ankit Bhardwaj | Contact | 011-46300000 | 1032 | bhardwaj.ankit3@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Naveen Kumar, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| 2HRLE/4HR | Drug | Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months |
|
| 9HLE | Drug | Isoniazid+ Levofloxacin+ Ethambutol for 9 months |
|
| 9RLE | Drug | Rifampicin + Levofloxacin+ Ethambutol for 9 months |
|
| Survival | 6 and 9 months |