New TB Drug Trials in India Likely

Trials on a new, shorter regimen drug for TB could start in India soon. The international trial will look at whether the drug Moxifloxacin actually increases cure rate and helps shorten the duration of treatment for tuberculosis patients. It is billed as one of the world’s largest ever TB trials.

Belonging to a class of drugs called fluoroquinolone antibiotics, Moxifloxacin works by stopping the lifecycle of a harmful bacteria.

Scientists have identified it as a drug with the potential to cut the length of treatment from the present six months to four months when used in combination with other popular TB drugs.

It has been proposed to recruit 2,400 fresh TB patients in over 20 sites across the globe.

Melvin Spigelman, Global Alliance for TB Drug Development’s director of research and development, told the Times of India, “At present, four sites in South Africa, Zambia and Tanzania are already recruiting patients for the study. We are also looking at sites India, China, Hong Kong and Kenya.”

He added, “The problem with TB treatment regimens at present is that they are complicated. We don’t want to add another drug to the already existing four drug regimen. We want to see if Moxifloxacin, which has shown excellent safety profile and proved highly effective in clearing the TB bacteria within four months during the phase-II trials, actually cures faster when it substitutes existing drugs ethambutol or isoniazid.”

The $20 million study would be financed mostly by the TB Alliance and Bill and Melinda Gates Foundation.

Prof Andrew Nunn from Medical Research Council, UK’s Clinical Trials Unit, who was part of the trials that in the 1980s reduced treatment regimen from 18-24 months to the present day 6-9 months, said, “Reduction of treatment time to four months would mean less exposure to drugs for the patient and less interaction with health services thereby reducing their workload.”

He said the duration of the treatment made adherence a significant continuing problem. Incomplete adherence can lead to failure of cure, or relapse. In view of the escalating number of cases of TB globally, there is an urgent need for treatment combinations of shorter duration.

The REMox TB study is a double-blind, randomised, placebo controlled study which means that neither the patients nor the staff caring for them will know which combination they are taking.

Three Indian sites — Christian Medical College (Vellore), TB Research Centre (Chennai) and National Tuberculosis Institute (Bangalore) — are under active consideration for being part of the global consortium to conduct the trial. The final results from the study are expected by early 2011. Experts say that shorter regimens boost drug compliance and cure rates by as much as 50%.

Source-Medindia
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