Health Condition 1: null- Tuberculosis
Conditions
Interventions
Intervention1: Novel fixed dose combination of rifampicin (450 MG) and isoniazid (300 MG): Novel gastroretentive time-modulated release FDC of Rifampicin and Isoniazid with better bioavailability.
Dur
Sponsors
Department of Pharmaceuticals Ministry of Chemical Fertilizers
Eligibility
Inclusion criteria
Inclusion criteria: • Confirmed TB with demonstration of M. Tb. In sputum smear and culture. • Patients with clinical features like cough, fever, anorexia and weight loss. • Chest radiograph compatible with diagnosis of pulmonary TB • Patients willing to give written informed consent. • HIV negative
Exclusion criteria
Exclusion criteria: • Serious form of pulmonary or extra-pulmonary TB (eg. Severe haemoptysis and unconscious patients) • Presence of chronic liver disease and renal insufficiency • Concomitant administration of potential hepatotoxic drugs (eg. methotrexate, phenytoin and valproate) • Chronic alcoholics who consume more than 48 gram of alcohol per day for at least 1 year. • Subjects not willing to participate and continue. • HIV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of therapy and drug levels to be used in this trial at 6 monthsTimepoint: 6 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| drug levels to be used in this trialTimepoint: Time points for drug levels;To check the potentially of novel FDC to reduce the treatment durationTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDR SANJEEV SINHA
epartment of Medicine All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110 029
Outcome results
None listed