{"id":5642,"date":"2006-03-08T13:17:55","date_gmt":"2006-03-08T12:17:55","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=5642"},"modified":"2013-12-07T08:01:37","modified_gmt":"2013-12-07T08:01:37","slug":"treatment-naive-trial-of-tipranavir-discontinues-highest-dose-arm","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/5642","title":{"rendered":"Treatment-naive trial of tipranavir discontinues highest dose arm"},"content":{"rendered":"<p><strong>Boehringer Ingelheim issued a clinical trial statement on 23 February providing details on the discontinuation of one arm of its trial of tipranavir\/r in treatment naive patients.<\/strong><\/p>\n<p>This followed a recommendation from the Data Safety Monitoring Board (DSMB) for study 1182.33 to close the tipranavir\/ritonavir 500 mg\/200 mg study arm, based on 48-week safety data. Specifically, the rate of asymptomatic liver enzyme elevations reported in the tipranavir\/ritonavir 500 mg\/200 mg study arm was higher than in the other study arms and presented a less favorable benefit-risk profile for these treatment-naive patients.<\/p>\n<p>The tipranavir\/ritonavir 500 mg\/100 mg study arm and lopinavir\/ritonavir comparator arm in this trial will continue.<\/p>\n<p>The benefit-risk profile has not changed for the highly treatment-experienced patient population for which tipranavir\/ritonavir (500 mg\/200 mg) is currently indicated. The rate of asymptomatic liver enzyme elevations in highly treatment-experienced patients in the RESIST clinical trial programme was lower than that observed in the 500 mg\/200 mg arm of study 1182.33 in treatment-naive patients.<\/p>\n<p>Source: BI Clinical Trial Statement: \u0091Boehringer Ingelheim provides update on study arms of Aptivus (tipranavir) clinical trial in treatment-naive HIV-infected patients\u0092. 23 February 2006.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Boehringer Ingelheim issued a clinical trial statement on 23 February providing details on the discontinuation of one arm of its trial of tipranavir\/r in treatment naive patients. This followed a recommendation from the Data Safety Monitoring Board (DSMB) for study &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-5642","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/5642","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=5642"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/5642\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=5642"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=5642"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=5642"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}