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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Chronic Liver Disease With Tuberclosis

Treatments: Drug: 9RLE; Drug: 2HRLE/4HR; Drug: 2HRZE/4HR; Drug: 9HLE

Study type: Interventional

Funder types: Other

Identifiers

NCT01677871

ILBS-ATT-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or Females subjects aged 18-75 years.
• Subjects with chronic liver disease (cirrhosis)
• Pulmonary or extra-pulmonary tuberculosis.
• Serum ALT≤5times upper limit and serum bilirubin ≤3 mg/dl.
• consent and willingness to follow-up

Exclusion criteria

• Serum ALT>5times upper limit and serum bilirubin >3 mg/dl.
• Renal failure (serum creatinine>2mg/dl).
• Presence of hepatocellular carcinoma
• Alcoholic cirrhotic who continue to drink alcohol.
• Prior history of ATT (ANTI TUBERCULAR TREATMENT) with documented hepatotoxicity.
• Known hypersensitivity to levofloxacin, other quinolones

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 4 patient groups

2HRZE/4HR

Experimental group

Description:

Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months

Treatment:

Drug: 2HRLE/4HR

2HRLE/4HR

Active Comparator group

Description:

Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months

Treatment:

Drug: 2HRZE/4HR

9HLE

Experimental group

Description:

Isoniazid+ Levofloxacin+ Ethambutol for 9 months

Treatment:

Drug: 9RLE

9RLE

Active Comparator group

Description:

Rifampicin + Levofloxacin+ Ethambutol for 9 months

Treatment:

Drug: 9HLE