drugset / Trial / NCT01677871

Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease

NCT01677871

RandomizedParallel-groupOpen-labelTreatment

Summary

During the Study: * Subject is required to visit every week for the first 2 months and then every month till completion of study or as and when required * The usual symptomatic and supportive treatment of Chronic Liver Disease, including use of antiviral, will be given to all patients. * Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular Treatment. * Liver function tests (LFT) will be done weekly during first 2 months then at one month interval or as when required. * The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9. Patients not improving at 4 weeks after initiation of treatment will be shifted to alternative regimens and will be excluded from the study.

Timeline

Start
2012-09
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ethambutol Small molecule
Comparator Isoniazid Small molecule
Subject Levofloxacin Small molecule
Comparator Pyrazinamide Small molecule
Comparator Rifampin Small molecule

Indications