{"id":2477,"date":"1998-12-31T00:00:10","date_gmt":"1998-12-30T17:00:10","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=2477"},"modified":"2022-03-30T10:09:39","modified_gmt":"2022-03-30T03:09:39","slug":"a-phase-two-randomized-four-arm-open-label-comparative-trial-to-evaluate-the-efficacy-and-tolerance-of-combination-antiretroviral-therapy-with-ddi-d4t-alone-or-in-combination-with-either-nevirapi","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/2477\/","title":{"rendered":"A phase 2 randomized, four arm, open-label, comparative trial to evaluate the efficacy and tolerance of combination antiretroviral therapy with ddI + d4T alone or in combination with either nevirapine, hydroxyurea or both nevirapine and hydroxyurea for the treatment of HIV-1 infection in a Thai study population"},"content":{"rendered":"\n<p><strong>Project no.:<\/strong> HIV-NAT 006<\/p>\n\n\n\n<p><strong>Introduction:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Hydroxyurea (HU) blocks DNA synthesis by inhibitoion of the cellular enzyme ribonucleotide reductase. It has been shown in vitro to block HIV-1 infection in acutely infected human lymphocytes and macrophages. In vitro synergy with ddI has also been demonstrated<\/li><li>Nevirapine, the first drug developed in the non-nucleoside class, has been shown to have beneficial effects on CD cell counts and HIV-1 viral load when given with combination nucleoside antiretroviral regimens<\/li><\/ul>\n\n\n\n<p><strong>Study Regimens:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>ddI + d4T<\/li><li>ddI + d4T + hydroxyurea<\/li><li>ddI + d4T + nevirapine<\/li><li>ddI + d4T + nevirapine + hydroxyurea<\/li><\/ul>\n\n\n\n<p><strong>Study Objectives:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Primary:<ul><li>To compare the time weighted change in plasma HIV-1 RNA load from baseline in each arm as a measure of relative efficacy<\/li><li>To access safety and tolerance of the four different regimens based in clinical and laboratory adverse events<\/li><\/ul><\/li><li>Secondary:<ul><li>To evaluate the time weighted changed in absolute CD4+ cell counts and CD4\/CD8 ratio from baseline in each regimens<\/li><li>To access efficacy of the different regimens on survival and HIV disease progression <\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>Study Design:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Total of 200 antiretroviral na\u00efve participants will be recruited over a 6 month period and equally randomized to one of the four study arms<\/li><li>Participants should have CD4+ cell count of at least 150 cells\/nn<sup>3<\/sup> and HIV-RNA viral load of at least 10,000 copies\/ml<\/li><li>Duration of study is 48 weeks<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tHydroxyurea (HU) blocks DNA synthesis by inhibitoion of the cellular enzyme ribonucleotide reductase. It has been shown in vitro to block HIV-1 infection in acutely infected human lymphocytes and macrophages. In vitro synergy with ddI has also been demonstrated\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-2477","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2477","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=2477"}],"version-history":[{"count":1,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2477\/revisions"}],"predecessor-version":[{"id":3357,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2477\/revisions\/3357"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=2477"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=2477"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=2477"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}