{"id":2462,"date":"1998-12-31T00:00:14","date_gmt":"1998-12-30T17:00:14","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=2462"},"modified":"1998-12-31T00:00:14","modified_gmt":"1998-12-30T17:00:14","slug":"a-randomized-open-label-comparative-trial-of-azt-3tc-ddi-om-antiretroviral-naive-hiv-1-infected-in-thai-patients","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/2462\/","title":{"rendered":"A randomized, open-label, comparative trial of AZT\/3TC\/ddI om antiretroviral na\u00efve HIV-1 infected in Thai patients"},"content":{"rendered":"\n\t\t\t\t\n<p><strong>Project no.:<\/strong> HIV-NAT 003<\/p>\n\n\n\n<p><strong>Background: <\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>An in vitro study comparing the ability of ten different three-drug combinations to prevent HIV-induced cytopathic effects in a continuous T-lymphoblastoid cell line showed superior activity of AZT\/3TC\/ddI.<\/li><li>This study will compare the triple combination of AZT\/3TC\/ddI versus a control arm of AZT\/3TC<\/li><li>Triple nucleosides regimens may be an appropriate alternative to costlier protease inhibitor-containing regimens <\/li><\/ul>\n\n\n\n<p><strong>Objectives:<\/strong> To evaluate tolerance and comparative virologic and immunologic efficacy of AZT in combination with 3TC versus AZT in combination with 3TC and ddI<\/p>\n\n\n\n<p><strong>Trial design:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Randomized, open label, comparative, two-center study<\/li><li>Primary endpoint will be suppression of plasma HIV-RNA and absolute change in CD4 cells\/mm<sup>3<\/sup> from baseline<\/li><li>The duration of the study is 48 weeks <\/li><\/ul>\n\n\n\n<p><strong>Treatment: <\/strong>AZT 300 (200*) mg + 3TC 150 mg BID<\/p>\n\n\n\n<p><strong>Arm: <\/strong>AZT 300 (200*) mg + 3TC 150 mg + ddI 200 (125*) mg BID<br>* if subject weight &lt; 60 kg<\/p>\n\n\n\n<p><strong>Entry criteria:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Antitretroviral naive<\/li><li>CD4+ cell count of 100-500 \/mm<sup>3<\/sup><\/li><li>No active or ongoing opportunistic infection disease<\/li><\/ul>\n\n\n\n<p><strong>Methods:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>106 HIV-1 infected Thai with CD4 counts between 100 and 500 cells\/mm<sup>3<\/sup>, free from any active or ongoing opportunistic infection were equally randomized to received either AZT\/3TC or AZT\/3TC\/ddI for 48 weeks.<\/li><li>Patients were assessed at screening, randomization, and at weeks 2, 4, 12, 24, 36, and 48 to determine:<ul><li>the degree and duration of plasma HIV-RNA reduction as measured by bDNA assay (limit of detection 500 copies\/ml)<\/li><li>changes in CD4+ lymphocyte count<\/li><li>Safety and tolerance of the treatment regimes<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>Results:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Both regimens were well tolerated.<\/li><li>Adverse events related to study drug were mild and equally distributed between the two arms<\/li><li>The three most frequent adverse events were nausea, vomiting and anorexia.<\/li><li>Laboratory abnormalities include 1 patient with Grade IV neutropenia and Grade III anemia at week 12-19 and 1 patient with Grade III anemia and Grade IV neutropenia at week 12-14 which resolved upon temporally treatment descontinuation. 1 patient had grade IV ALT at the day of beginning study treatment. <\/li><li>Reduction in viral load was significantly greater in the AZT\/3TC\/ddI arm compared to the AZT\/3TC arm (p = 0.0031) when ultrasensitive assay (LD 50 copies\/ml) was used.<\/li><\/ul>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tAn in vitro study comparing the ability of ten different three-drug combinations to prevent HIV-induced cytopathic effects in a continuous T-lymphoblastoid cell line showed superior activity of AZT\/3TC\/ddI.\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-2462","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2462","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=2462"}],"version-history":[{"count":0,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2462\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=2462"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=2462"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=2462"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}