The STREAM clinical trial has enrolled its 400th patient, meeting the recruitment target for Stage 1 of the comparison of a shorter 9-month treatment regimen for multidrug-resistant tuberculosis (MDR-TB) with the World Health Organization-approved treatment regimen.
The STREAM (Standardised Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB) trial, sponsored by The Union and implemented by the Medical Research Council at University College London, is taking place at seven sites in South Africa, Ethiopia, Viet Nam and Mongolia. The sites are located a variety of settings and include patients with HIV co-infection.
In Stage 1, the objectives are to determine whether the proportion of patients with a successful outcome on the shorter treatment regimen is at least as good as that observed in the longer, control regimen.
The reason for this “non-inferiority” design of the trial is that, with its considerably reduced pill burden and duration – as well as the expected increase in adherence – the shorter regimen needs only to show that it is not less effective than the control regimen to become the new standard.
The success of Stage 1 implementation has also led to the opportunity to test two other regimens of particular public health interest and relevance: Beginning this summer, the trial will also include the evaluation of an all-oral treatment that eliminates the painful injections now required, and an even shorter, simplified regimen. These new treatment regimens will incorporate the recently approved medicine Bedaquiline. This amended STREAM Protocol (Stage 2) has been approved by the US Federal Drug Administration (FDA) and the European Medicines Agency (EMA) for Bedaquiline regulatory purposes, as well as The Union’s Ethics Advisory Group.
Although the original plan was to enrol only 400 patients into STREAM Stage 1, Dr I.D. Rusen, Senior Vice President for Research and Development at The Union North America, says they plan to continue to enroll patients into Stage 1 of the trial until Stage 2 is ready for enrolment. Results from Stage 1 of the trial are expected in late 2017 with Stage 2 results anticipated in 2020.
Funding for STREAM Stage 1 comes primarily from the United States Agency for International Development (USAID) with additional funding from the UK Medical Research Council and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement. Stage 2 will also include financial support from Janssen Pharmaceuticals – the makers of Bedaquiline.