{"id":2479,"date":"1998-12-31T00:00:03","date_gmt":"1998-12-30T17:00:03","guid":{"rendered":"https:\/\/www.hivnat.org\/en\/?p=2479"},"modified":"1998-12-31T00:00:03","modified_gmt":"1998-12-30T17:00:03","slug":"a-study-of-the-safety-tolerance-and-pharmacokinetics-of-nelfinavir-co-administered-with-stavudine-d4t-and-didanosine-ddi-in-hiv-exposed-infants","status":"publish","type":"post","link":"https:\/\/www.hivnat.org\/en\/studies\/2479\/","title":{"rendered":"A study of the safety, tolerance and pharmacokinetics of Nelfinavir co-administered with Stavudine (d4T) and Didanosine (ddI) in HIV-exposed infants"},"content":{"rendered":"\n\t\t\t\t\n<p><strong>Project no.: <\/strong>HIV-NAT 007<\/p>\n\n\n\n<p><strong>Background:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The pediatric oral powder formulation of Nelfinavir has been studied in small groups of HIV-infected children<\/li><li>Serveral small pediatric trials suggest Nelfinavir as part of a combination regimen is generally well tolerated and has the same potential clinical benefit that have been noted in adults<\/li><li>This study will provide information to be used further in a propose phase 3 study  <\/li><\/ul>\n\n\n\n<p>Study population: 12-36 evaluable newborn infants born to HIV-infected women<\/p>\n\n\n\n<p><strong>Regimen:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Nelfinavir 15 mg\/kg PO every 12 hours*<\/li><li>d4T 1 mg\/kg PO every 12 hours<\/li><li>ddI 100 mg\/m<sup>2<\/sup> PO every 24 hours<\/li><li><\/li><\/ul>\n\n\n\n<p>*Analysis of the pharmacokinetic data from the first cohort (21 infants) may require recruitment for the next cohort in which Nelfinavir dose will be increased (30 mg\/kg &amp; 45 mg\/kg BID)<\/p>\n\n\n\n<p><strong>Objectives:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>To access the safety and tolerance of the triple combination regimen of Nelfinavir, d4T and ddI in HIV-exposed newborn infants<\/li><li>To determine the appropriate dosage of Nelfinavir and to access its pharmacokinetics when given in combination with d4T and ddI in HIV-exposed newborn infants<\/li><\/ul>\n\n\n\n<p><strong>Study Design:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>An open label, dose-escalating, multiple-dose pharmacokinetic study<\/li><li>The regimen will be administered to infants, within 12 hours of birth born to HIV-infected women all of whom should have received Zidovudine prophylactic regimen during pregnency and labor as standard of care<\/li><li>In addition to receiving d4T and ddI, infants will receive Nelfinavir 15 mg\/kg BID for the first cohort, 30 mg\/kg BID for the second cohort and 45 mg\/kg for the third cohort for a period of 4 weeks<\/li><li>Quantification of plasma Nelfinavir concentrations and pharmacokinetic analysis will be run on a real time basis and the dose of Nelfinavir adjusted for each cohort as required<\/li><li>All infants will be followed for 4 months after birth to determine their HIV infection status <\/li><\/ul>\n\n\n\n<p><\/p>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\t\t\t\tThe pediatric oral powder formulation of Nelfinavir has been studied in small groups of HIV-infected children\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-2479","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2479","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=2479"}],"version-history":[{"count":0,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/2479\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=2479"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=2479"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=2479"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}