PanACEA MAMS-TB-01 trial: ‘high-dose rifampicin may help shorten TB treatment’
26 February 2015
Today, the EDCTP-funded PanACEA consortium released a statement on the preliminary results from the MAMS-TB-01 clinical trial which were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2015. High-dose (35mg/kg) rifampicin, in combination with standard dose of isoniazid, pyrazinamide and ethambutol, showed a significant shortening of time to culture conversion with a covariate-adjusted hazard ratio of 1.75, 95% confidence interval (1.21-2.55) over the 12 weeks of experimental treatment. Data on treatment up to week 26 and post-treatment follow-up will be analysed and reported together with the results mentioned above in the future main publication.
“This is the largest reduction in time to culture conversion seen in any previous TB trial, to our knowledge. High doses of rifampicin may be an important component in shorter TB regimens in the future.”
Chief Investigator Martin Boeree (Radboud University Nijmegen, The Netherlands)
The MAMS-TB-01 trial enrolled 365 patients from 7 sites in Tanzania and South Africa in only 11 months. It is the first of several TB treatment regimen trials which will use the same innovative adaptive clinical trial design that allows several new regimens to be compared to the current standard, and incorporates interim analyses that allow for regimens that show little treatment shortening potential to be excluded from the trial at an early stage.
“To our knowledge, this is the first trial with an adaptive design evaluating multiple combination treatment regimens in a global health setting. We have shown that novel trial methodology originally developed for oncology trials can successfully be used to evaluate new treatments for tuberculosis.”
Dr Patrick Phillips (University College London, United Kingdom)