{"id":2306,"date":"2006-08-03T17:18:59","date_gmt":"2006-08-03T16:18:59","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=2306"},"modified":"2013-12-06T17:40:06","modified_gmt":"2013-12-06T17:40:06","slug":"boehringer-stops-tipranavir-trial-in-treatment-naive-patients","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/2306","title":{"rendered":"Boehringer stops tipranavir trial in treatment-naive patients"},"content":{"rendered":"

On 13 June 2006, Boehringer Ingelheim announced that it was closing a clinical trial of HIV drug tipranavir (Aptivus) in treatment-naive patients due to insufficient effectiveness at 60 weeks.<\/strong><\/p>\n

Tipranavir was approved in Europe in October 2005 and is currently only indicated in combination with ritonavir in treatment-experienced patients who are resistant to other PIs.<\/p>\n

The study that has now been closed, BI 1182.33, recruited 558 treatment-naive patients in 15 countries including France, Germany and the UK, and was a non-inferiority trial against lopinavir\/r (Kaletra), whose primary endpoint was the proportion of patients with an undetectable viral load (< 50 copies\/mL).<\/p>\n

Patients in both tipranavir arms received 500 mg tipranavir twice daily. Only the ritonavir dose varied, at 200 mg or 100 mg twice daily.<\/p>\n

For both doses of ritonavir, tipranavir\u0092s non-inferiority was proved at 48 weeks.<\/p>\n

However, following this, the 200 mg ritonavir arm was closed due to an asymptomatic elevation of liver enzyme levels. This phenomenon had already been observed in the RESIST treatment-experienced trials.<\/p>\n

A subsequent 60-week analysis, showed that the effect of tipranavir\/ritonavir (500 mg\/100 mg twice daily) had declined and that this therapy was now inferior to Kaletra in terms of virologic success.<\/p>\n

The press release does not specify the proportion of patients with undetectable viral loads, but says that there was a 15.03% difference between the lopinavir\/r and tipranavir arms, 0.3% above the limit fixed in the trial protocol.<\/p>\n

Boehringer Ingelheim decided at this point to halt the whole trial, specifying that this \u0093does not change the positive benefit-risk profile of tipranavir\/ritonavir (500 mg\/200 mg) for the highly treatment-experienced patient population for which it is currently indicated.\u0094<\/p>\n

Source: Boehringer Ingelheim Press Release (13 June 2006)<\/p>\n","protected":false},"excerpt":{"rendered":"

On 13 June 2006, Boehringer Ingelheim announced that it was closing a clinical trial of HIV drug tipranavir (Aptivus) in treatment-naive patients due to insufficient effectiveness at 60 weeks. Tipranavir was approved in Europe in October 2005 and is currently …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-2306","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2306","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=2306"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2306\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=2306"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=2306"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=2306"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}