{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:45:05Z","timestamp":1777380305085,"version":"3.51.4"},"reference-count":10,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["AIDS Research and Human Retroviruses"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:p>\n                    APV20002 was a multicenter, international, open-label study that began in 2003 investigating the pharmacokinetics, efficacy, and safety of ritonavir-boosted fosamprenavir (FPV\/r) oral solution (OS) in combination with nucleoside reverse transcriptase inhibitor-based antiretroviral therapy (ART) in participants living with HIV-1 aged 4 weeks to &lt;2 years with a primary endpoint at Week 48 (48W). Participants in APV20002 could continue in the study post-48W until FPV OS was locally available in their countries. Children were required to discontinue after reaching &gt;39 kg or if FPV OS had no clinical benefit. Fifty-nine participants were enrolled; 5\/59 received a single FPV OS visit for pharmacokinetic determinations. Most (38\/54; 70%) were antiretroviral experienced; 39\/59 participants had &gt;48 weeks on treatment, 4\/39 of whom discontinued after 48 weeks due to an adverse event (AE). At 48W, 88% of participants had HIV-1 RNA &lt;400 copies\/mL by Observed analysis; the proportion with HIV-1 RNA &lt;400 copies\/mL remained high (84%\u2212100%) through Week 684. The median CD4\n                    <jats:sup>+<\/jats:sup>\n                    cell count was 1,235 cells\/mm\n                    <jats:sup>3<\/jats:sup>\n                    [\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    = 51] at baseline, 1,690 cells\/mm\n                    <jats:sup>3<\/jats:sup>\n                    (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    = 41) at Week 48, and 1,280 cells\/mm\n                    <jats:sup>3<\/jats:sup>\n                    (\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    = 21) at Week 180. From baseline to Week 684, 54\/59 (92%) participants had \u22651 treatment-emergent AE regardless of causality; 42\/59 (71%) had a treatment-emergent grade 2\u20134 AE, predominantly maximum toxicity: grade 2; 21\/59 (36%) and 21\/59 (36%) had severe or grade 3\/4 AEs. From baseline to Week 684, 14\/54 (26%) participants met virologic failure (VF) criteria, 9\/14 before 48W. HIV from 1\/9 VFs through 48W developed treatment-emergent reduced susceptibility to FPV and 1\/9 to lamivudine\/emtricitabine. Post-48W, 4\/5 participants with VF had phenotype results; all were still susceptible to all study drugs at VF. In conclusion, FPV OS-based ART was efficacious and generally well tolerated in this long-running pediatric study through 684 weeks of treatment, with a safety profile consistent with experience in adults and older children.\n                  <\/jats:p>","DOI":"10.1089\/aid.2024.0020","type":"journal-article","created":{"date-parts":[[2024,7,8]],"date-time":"2024-07-08T04:54:10Z","timestamp":1720414450000},"page":"606-613","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Study APV20002: Safety and Efficacy Results Through Week 684 for Pediatric Participants Living with HIV-1 Treated with Ritonavir-Boosted Fosamprenavir Oral Solution\u2013Based Antiretroviral Therapy"],"prefix":"10.1177","volume":"40","author":[{"given":"Lisa L.","family":"Ross","sequence":"first","affiliation":[{"name":"ViiV Healthcare, Durham, North Carolina, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark F.","family":"Cotton","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Child Health, Children\u2019s Infectious Diseases Clinical Research Unit, Stellenbosch University, Tygerberg, South Africa."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haseena","family":"Cassim","sequence":"additional","affiliation":[{"name":"Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harmony P.","family":"Garges","sequence":"additional","affiliation":[{"name":"ViiV Healthcare, Durham, North Carolina, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sven C.","family":"van Dijkman","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Brentford, United Kingdom."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kishen","family":"Morarji","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Brentford, United Kingdom."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Supriya","family":"Karthika","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Brentford, United Kingdom."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"Danehower","sequence":"additional","affiliation":[{"name":"ViiV Healthcare, Durham, North Carolina, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacob","family":"Radford","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Brentford, United Kingdom."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Butcher","sequence":"additional","affiliation":[{"name":"ViiV Healthcare, Brentford, United Kingdom."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2024,10,8]]},"reference":[{"key":"e_1_3_6_2_2","unstructured":"UNAIDS. World AIDS Day 2023 fact sheet: Global HIV statistics. Available from: https:\/\/www.unaids.org\/sites\/default\/files\/media_asset\/UNAIDS_FactSheet_en.pdf [Last accessed: February16 2024]."},{"key":"e_1_3_6_3_2","unstructured":"UNICEF. Paediatric care and treatment. 2023. Available from: https:\/\/data.unicef.org\/topic\/hivaids\/paediatric-treatment-and-care [Last accessed: February16 2024]."},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e3182a1123a"},{"key":"e_1_3_6_5_2","doi-asserted-by":"publisher","DOI":"10.2174\/1874613601509010038"},{"key":"e_1_3_6_6_2","unstructured":"Division of AIDS NIAID. Toxicity Tables. Tables for grading severity of pediatric adverse experiences. Version 1.0. 2004. Available from: https:\/\/rsc.niaid.nih.gov\/sites\/default\/files\/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf [Last accessed: February19 2024]."},{"key":"e_1_3_6_7_2","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e3182a1126a"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1080\/09540121.2019.1668530"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000459"},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10461-021-03198-9"},{"key":"e_1_3_6_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10461-016-1537-0"}],"container-title":["AIDS Research and Human Retroviruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/aid.2024.0020","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/aid.2024.0020","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/aid.2024.0020","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T09:16:58Z","timestamp":1777367818000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/aid.2024.0020"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10]]},"references-count":10,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2024,10]]}},"alternative-id":["10.1089\/aid.2024.0020"],"URL":"https:\/\/doi.org\/10.1089\/aid.2024.0020","relation":{},"ISSN":["0889-2229","1931-8405"],"issn-type":[{"value":"0889-2229","type":"print"},{"value":"1931-8405","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10]]}}}