India: ICMR to conduct clinical trials for evaluating TB drugs and vaccines

In this regard, the apex research organization in the country has now invited Letter of Interest (LOI) from government hospitals, medical colleges, research institutions/organizations and private hospitals and practitioners for conducting clinical trials for evaluating tuberculosis drugs and vaccines.

The list of proposed clinical trials included a phase-I, open label, parallel group, pharmacokinetic and efficacy study of rifampicin (450 mg and 600mg) and Piperine (225 mg) compared with standard rifampicin therapy in newly diagnosed sputum positive pulmonary tuberculosis patients as an adjuvant to the standard TB therapy; a phase IIb open label randomized controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics and anti-bacterial activity of high dose rifampicin when given along with other anti- TB drugs in adults with newly diagnosed pulmonary tuberculosis; a double-blind, placebo-controlled comparative study for safety and efficacy of Metformin HCL in combination with ATT as adjunct therapy; a phase–III multicentric open label randomized clinical trial to assess the efficacy and safety of delamanid in combination with bedaquiline, linezolid and clofazimine in participants with XDR-TB; and inhibition of host-induced mycobacterial efflux pumps as a novel strategy to counter drug tolerance and virulence of pulmonary tuberculosis.  

The list also included a randomized controlled clinical trial on the safety and efficacy of delamanid in the prevention of TB among latent TB infected household contacts of multidrug resistant pulmonary TB patients; early bactericidal activity (EBA) of rifampicin and feropenem in DS –TB patients; salvage regimen for XDR-TB; randomized, controlled, phase II study to evaluate safety, immunogenicity and POD after vaccination in a high risk group (IGRA positive subjects); and an open label safety observational study of inhaled gaseous nitric oxide (gNO) for adults with drug resistant pulmonary tuberculosis.

India is a signatory to the WHO Global End TB Strategy, which was approved by the World Health Assembly in May 2014. The strategy calls for a 90 per cent reduction in TB incidence and mortality by 2035 and an elimination of catastrophic health expenditure.

It is evident now that such a reduction cannot be achieved only with the existing tools & strategies. There is a strong need to undertake active research activities so as to identify newer ATT drug regimes, evaluate new drugs, test TB vaccines and validate new diagnostics tools.  The research results should be able to guide cost effective treatment guidelines for local needs and the TB control programme.

Keeping in view the stringent national and international guidelines for conduct of clinical trials, ICMR has decided to initiate conduct of clinical trials for regulatory submissions and for academic purposes.

Source: PharmaBiz