{"id":2416,"date":"1998-12-31T00:00:12","date_gmt":"1998-12-30T17:00:12","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=2416"},"modified":"1998-12-31T00:00:12","modified_gmt":"1998-12-30T17:00:12","slug":"a-randomized-open-label-follow-up-study-of-protocol-hiv-nat-001-to-explore-the-antiretroviral-efficacy-and-tolerability-of-switching-to-therapy-with-d4t-ddi-saquinavir-soft-gel-capsules-versus-combiv","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/2416\/","title":{"rendered":"A randomized, open-label follow-up study of protocol HIV-NAT 001 to explore the antiretroviral efficacy and tolerability of switching to therapy with d4T\/ddI\/Saquinavir soft gel capsules versus Combivir (AZT\/3TC)\/Saquinavir soft gel capsules in an HIV-infected Thai population pretreated with AZT and ddC for at least 48 weeks"},"content":{"rendered":"\n\t\t\t\t\n<p><strong>Project no.:<\/strong> HIV-NAT 001.1<\/p>\n\n\n\n<p><strong>Study Endpoint: <\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Primary: <ul><li>Percentage of patients achieving sustained undetectable HIV-1 RNA in plasma (Amplicor HIV-1 Moniror) at 48 weeks<\/li><li>Degree and duration of increase in CD4+ cell counts from baseline<\/li><\/ul><\/li><li>Secondary: Development of, or delay in development of, genotypic markers of reduced viral sensitivity to the study drugs<\/li><\/ul>\n\n\n\n<p>Study design: <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>All patients successfully completing 48 weeks of follow-up in study protocal 001 received open label AZT\/ddC in standard doses for another 18 weeks in an &#8216;extension phase&#8217; of study 001.<\/li><li>After a total of 66 weeks on study 001, they were switched to this study (001.1)<\/li><li>Participants monitored at baseline (week 66), weeks 70, 74, and every 8 weeks thereafter<\/li><\/ul>\n\n\n\n<p><strong>Result:<\/strong> A formal, interim analysis is currently in progress (Jan 1999)<\/p>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tStudy Endpoint: Primary: Percentage of patients achieving sustained undetectable HIV-1 RNA in plasma (Amplicor HIV-1 Moniror) at 48 weeks\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-2416","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2416","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=2416"}],"version-history":[{"count":0,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2416\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=2416"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=2416"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=2416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}