{"id":1841,"date":"2018-12-31T00:00:53","date_gmt":"2018-12-30T17:00:53","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=1841"},"modified":"2018-12-31T00:00:53","modified_gmt":"2018-12-30T17:00:53","slug":"two-month-regimens-using-novel-combinations-to-augment-treatment-effectiveness-for-drug-sensitive-tuberculosis","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/1841\/","title":{"rendered":"Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for drug-sensitive Tuberculosis (TRUNCATE-TB)"},"content":{"rendered":"\n\t\t\t\t\n<p class=\"wp-block-paragraph\"><strong>Project no.: <\/strong>HIV-NAT 237 (NCT03474198)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This is a two-month regimens using\nnovel combinations to augment treatment effectiveness for drug-sensitive\ntuberculosis (TB): a randomised controlled non-inferiority trial <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Brief\nsummary:<\/strong> The current standard management strategy for drug-sensitive\npulmonary tuberculosis (TB) is to treat with multiple drugs for 6 months,\nalthough patients often fail to adhere to the long treatment, leading to poor\nclinical outcomes including drug resistance, which is expensive and difficult\nto treat.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The\nTRUNCATE-TB trial evaluates an alternative strategy (the TRUNCATE-TB Management\nStrategy) comprising treatment for 2 months (8 weeks, extended to 12 weeks if\ninadequate clinical response) with a regimen predicted to have enhanced\nsterilising activity (&#8220;boosted regimen&#8221;) and monitoring closely after\ntreatment cessation. Those who relapse (predicted to be always drug sensitive\nand likely to occur early) will be retreated with a standard 6 month regimen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The\ntrial is a randomized, open-label, multi-arm, multi-stage (MAMS) trial to test\nthe hypothesis that the TRUNCATE-TB Management Strategy is non-inferior to the\nstandard management strategy in terms of longer-term outcomes (clinical status\nat 96 weeks). If non-inferiority is demonstrated then the\nadvantages\/disadvantages of implementing the strategy will be explored in\nsecondary outcomes (from patient and programme perspective).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens (180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens include new drugs (licensed drugs, repurposed from other indications) and optimized doses of standard drugs, selected based on consideration of maximal sterilising effect, absence of drug-drug interactions, as well as safety and tolerability over a period of 2 months. <\/p>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tThis is a two-month regimens using novel combinations to augment treatment effectiveness for drug-sensitive tuberculosis (TB): a randomised controlled non-inferiority trial \t\t<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24],"tags":[],"class_list":["post-1841","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1841","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/comments?post=1841"}],"version-history":[{"count":0,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1841\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=1841"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=1841"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=1841"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}