{"id":2460,"date":"1998-12-31T00:00:07","date_gmt":"1998-12-30T17:00:07","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=2460"},"modified":"2022-03-30T11:06:49","modified_gmt":"2022-03-30T04:06:49","slug":"a-phase-iii-open-label-follow-up-study-to-protocol-hiv-nat-002-1-to-explore-the-durability-of-the-antiretroviral-efficacy-and-durability-of-ddi-d4t-and-azt-3tc-in-a-population-originally-treated-wit","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/2460\/","title":{"rendered":"A phase 3, open-label, follow-up study to protocol HIV-NAT 002.1 to explore the durability of the antiretroviral efficacy and durability of ddI\/d4T and AZT\/3TC in a population originally treated with ddI\/d4T, and explore the efficacy of adding hydroxyurea to failing therapy with two nucleosides"},"content":{"rendered":"\n<p><strong>Study objective:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>To determine durability of the virological and immunological responses of participants on study 002.1 who were responders at week 96 and continued wirh 002.1 study medication<\/li><li>To switch those failing AZT\/3TC at or before week 96 back to ddI\/d4T (if responders to ddI\/d4T at time of first switch) to determine to what extent they may still benefit form ddI\/d4T<\/li><li>To add hydroxyurea to the last double nucleoside combination in those who have failed both ddI\/d4T and AZT\/3TC at week 96<\/li><li>To evaluate the efficacy and tolerability of hydroxyurea added to two failing double nucleoside combinations <\/li><\/ul>\n\n\n\n<p><strong>Study design:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>All consenting participants enrolled in protocol 002.1 who successfully completed 96 weeks on protocols 002 and 002.1 without significant toxicities were eligible to enroll in study HIV-NAT 002.2<\/li><li>Participants still responding to ddI\/d4T ot AZT\/3TC at week 96 remained on current medication.<\/li><li>Participants switched to AZT\/3TC while still responding to ddI\/d4T at week 48 (early switchers) ad who are failing AZT\/3TC at week their 88 visit or in the course of 002.2 are switched back to ddI\/d4T at the first following visit<\/li><li>Participants who at any timepoint during study 002.2 have failed both ddI\/d4T and AZT\/3TC will have hydroxyurea (500 mg BID) added to their last taken double nucleoside combination at first following visit.<\/li><li>Failure defined as viral load at any visit of 1 log<sub>10<\/sub> or greater above the nadir reached on the current regimen or a decline in CD4+ cell count of &gt; 30% from baseline (week 0) that is deemed significant by the investigator. <\/li><\/ul>\n\n\n\n<p><strong>Preliminary result:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>69 patients still on study<\/li><li>Tweo participants have had hydroxyurea added, one to failing AZT\/3TC therapy and one to a failing ddI\/d4T regimen.<\/li><li>Other results pending.<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tTo determine durability of the virological and immunological responses of participants on study 002.1 who were responders at week 96 and continued wirh 002.1 study medication\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-2460","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2460","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=2460"}],"version-history":[{"count":3,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2460\/revisions"}],"predecessor-version":[{"id":3483,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2460\/revisions\/3483"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=2460"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=2460"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=2460"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}