{"id":2454,"date":"1998-12-31T00:00:51","date_gmt":"1998-12-30T17:00:51","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=2454"},"modified":"1998-12-31T00:00:51","modified_gmt":"1998-12-30T17:00:51","slug":"a-randomized-open-label-study-to-explore-the-antiretroviral-efficacy-and-tolerability-of-immediate-versus-deferred-switching-from-ddi-d4t-to-azt-3tc-in-a-thai-hiv-1-infected-population-pretreated-wi","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/2454\/","title":{"rendered":"A randomized, open-label study to explore the antiretroviral efficacy and tolerability of immediate versus deferred switching from ddI\/d4T to AZT\/3TC in a Thai HIV-1 infected population, pretreated with ddI\/d4T"},"content":{"rendered":"\n\t\t\t\t\n<p><strong>Project no.:<\/strong> HIV-NAT 002.1<\/p>\n\n\n\n<p><strong>Background:<\/strong> This roll-over protocal followed study HIV-NAT 002. 71 patients were re-randomized to immediate switch to AZT\/3TC (at week 48) versus deferred switch when considered as failing ddI\/d4T treatment on study 002. Mirror image study is re-randomizing participants taking AZT\/3TC on HIV-NAT 003 to immediate versus deferred switch to ddI\/d4T.<\/p>\n\n\n\n<p><strong>Method:<\/strong> <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Re-randomization was based on defining ddI\/d4T failure as rebound of viral load (Chiron bDNA) of 1log<sub>10<\/sub> or more above nadir reached at week 36 or any time point thereafter. <\/li><li>According to this definition, 68 participants were still considered as responders<ul><li>31 randomized to immediate switch to AZT\/3TC<\/li><li>37 randomized to deferred switch and remained on ddI\/d4T<\/li><li>3 participants non-responders at week 48 and not eligible for re-randomized received AZT\/3TC at week 48. <\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>Follow up: <\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Clinical and laboratory evaluation every 8 weeks<\/li><li>Additional visit at 4 weeks after switch<\/li><\/ul>\n\n\n\n<p><strong>Results:<\/strong> <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>All participants reached week 88<\/li><li>Interim analysis performed<\/li><li>Both treatment arms were safe and well tolerated<\/li><li>One participant lost to follow up at week 72<\/li><li>67 re-randomized participants  remain on study<\/li><li>Final report will be presented as a poster at the 6<sup>th<\/sup> Conference on Retroviruses and Opportunistic Infections in Chicago Feb 1999<\/li><li>At week 88, 10 participnats in the deferred arm had been switched to AZT\/3TC<\/li><\/ul>\n\n\n\n<p><\/p>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tThis roll-over protocal followed study HIV-NAT 002. 71 patients were re-randomized to immediate switch to AZT\/3TC (at week 48) versus deferred switch when considered as failing ddI\/d4T treatment on study 002.\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-2454","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2454","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=2454"}],"version-history":[{"count":0,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2454\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=2454"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=2454"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=2454"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}