drugset / Trial / NCT01154959

Latency in Pulmonary Tuberculosis

NCT01154959 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The immune responses in latent tuberculosis are poorly understood. While it is difficult to define the onset of latency during natural infection, patients undergoing treatment for tuberculosis are driven into a state of latency or cure. The present study on the effect of 3 and 4 month regimens containing moxifloxacin in sputum smear and culture positive pulmonary tuberculosis (TRC Study number 24) offers us the opportunity to study definitive immune responses pre and post treatment. We will evaluate a variety of innate and adaptive immune responses in patients before and after treatment and our study will compare the differences in immuno-phenotype (eg. Markers of T, B and NK cell activation, proliferation and regulatory phenotype) and function (eg. Production of cytokines, proliferative responses to TB antigens) at different time points following treatment. In addition, since a small percentage of patients will undergo relapse following treatment, the kinetics of immune responses in these patients will used to assess immunological predictors of relapse in tuberculosis.

Timeline

Start
2010-02
Primary completion
2015-12
Completion
2016-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ethambutol Small molecule 800 mg —
Subject Isoniazid Small molecule 300 mg —
Subject Isoniazid Small molecule 600 mg —
Subject Moxifloxacin Small molecule 400 mg —
Subject Pyrazinamide Small molecule 1500 mg —
Subject Rifampicin Small molecule 450 mg —
Subject Rifampicin Small molecule 600 mg —