{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T21:26:47Z","timestamp":1790890007222,"version":"4.1.0"},"reference-count":18,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2010,1,1]],"date-time":"2010-01-01T00:00:00Z","timestamp":1262304000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2010,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The aim of this study was to evaluate the pharmacokinetics of lamivudine (3TC), stavudine (d4T) and nevirapine (NVP) in HIV-infected Malawian children receiving quartered tablet multiples of Triomune 40\u2122 (generic tablet [GT]) compared with individual generic liquid (GL) and trade liquid (TL).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This was a prospective randomized three-way crossover study. Patients (8\u2013&lt;12 kg, 18\u2013&lt;22 kg or 28\u2013&lt;32 kg body weight) taking Triomune 40\u2122 were recruited and randomized to receive GT twice daily (one-quarter, one-half or three-quarter tablets using Malawi treatment guidelines), GL twice daily (in the equivalent dose of GT) or TL twice daily (dosed using weight and age from US Department of Health and Human Services paediatric treatment guidelines). After 10 days of one formulation, 6-h pharmacokinetic sampling was performed, and patients were crossed over to subsequent formulations. Baseline concentration (C\n                      <jats:sub>0 h<\/jats:sub>\n                      ), area under the curve (AUC)\n                      <jats:sub>0-6 h<\/jats:sub>\n                      , maximum plasma concentration (C\n                      <jats:sub>max<\/jats:sub>\n                      ) and time to C\n                      <jats:sub>max<\/jats:sub>\n                      were generated for each antiretroviral treatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 7 males and 11 females (6 in each GT dosing group) with a median (range) age of 7.2 years (1.3\u2013 13.6), weight of 19 kg (9.0\u201330.5) and height of 109 cm (75\u2013132) were recruited. Combining all patients, no difference in pharmacokinetics was noted among the formulations for all drugs. However, patients in the one-quarter GT dosing group (8\u2013&lt;12 kg) had lower 3TC exposures than with the GL or TL (3TC AUC\n                      <jats:sub>0-6 h<\/jats:sub>\n                      1,102, 1,720 and 2,060 h\u2022ng\/ml, respectively; P&lt;0.005) and had more subtherapeutic NVP C\n                      <jats:sub>0 h<\/jats:sub>\n                      (10 of 13 occasions versus the one-half and three-quarter tablet groups). Compared with Western paediatric cohorts, Malawians had concentrations 30\u201340% lower for 3TC and d4T and 50% higher for NVP.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Quartered multiples of Triomune 40\u2122 are appropriate for children 18\u2013&lt;22 kg and 28\u2013&lt;32 kg in weight; however, alternative formulations are suggested in children weighing 8\u2013&lt;12 kg.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3851\/imp1488","type":"journal-article","created":{"date-parts":[[2010,1,29]],"date-time":"2010-01-29T08:35:41Z","timestamp":1264754141000},"page":"83-90","source":"Crossref","is-referenced-by-count":14,"title":["Pharmacokinetics of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian children"],"prefix":"10.1177","volume":"15","author":[{"given":"Amanda H","family":"Corbett","sequence":"first","affiliation":[{"name":"University of North Carolina Schools of Pharmacy, Medicine and Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"},{"name":"University of North Carolina Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mina C","family":"Hosseinipour","sequence":"additional","affiliation":[{"name":"University of North Carolina Schools of Pharmacy, Medicine and Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"},{"name":"University of North Carolina Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"},{"name":"University of North Carolina Project, Lilongwe, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Nyirenda","sequence":"additional","affiliation":[{"name":"University of North Carolina Project, Lilongwe, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecelia","family":"Kanyama","sequence":"additional","affiliation":[{"name":"University of North Carolina Project, Lilongwe, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naser L","family":"Rezk","sequence":"additional","affiliation":[{"name":"University of North Carolina Schools of Pharmacy, Medicine and Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"},{"name":"University of North Carolina Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pax","family":"Mkupani","sequence":"additional","affiliation":[{"name":"University of North Carolina Project, Lilongwe, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorothy","family":"Sichali","sequence":"additional","affiliation":[{"name":"University of North Carolina Project, Lilongwe, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hsiao","family":"Tien","sequence":"additional","affiliation":[{"name":"University of North Carolina Schools of Pharmacy, Medicine and Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"},{"name":"University of North Carolina Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela DM","family":"Kashuba","sequence":"additional","affiliation":[{"name":"University of North Carolina Schools of Pharmacy, Medicine and Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"},{"name":"University of North Carolina Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Mwansambo","sequence":"additional","affiliation":[{"name":"Kamuzu Central Hospital, Lilongwe, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralf","family":"Weigel","sequence":"additional","affiliation":[{"name":"Lighthouse Clinic, Lilongwe, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Kazembe","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine Children's Foundation, Lilongwe, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2010,1,1]]},"reference":[{"key":"bibr1-IMP1488","unstructured":"UNAIDS, WHO. AIDS Epidemic Update 2007. (Accessed 1 July 2009.) Available from http:\/\/data.unaids.org\/pub\/EPISlides\/2007\/2007_epiupdate_en.pdf."},{"key":"bibr2-IMP1488","unstructured":"WHO. Malawi summary country profile for HIV\/AIDS treatment scale-up 2005. (Accessed 1 July 2009.) Available from http:\/\/www.who.int\/hiv\/HIVCP_MWI.pdf."},{"key":"bibr3-IMP1488","unstructured":"Malawi Ministry of Health. ART in the public and private sectors in Malawi: results up to 30th December 2007. Lilongwe, Malawi: Ministry of Health 2007."},{"key":"bibr4-IMP1488","doi-asserted-by":"crossref","first-page":"2648","DOI":"10.1001\/jama.289.20.2648-c","volume":"289","author":"Penzak S.R.","year":"2003","journal-title":"JAMA"},{"key":"bibr5-IMP1488","doi-asserted-by":"publisher","DOI":"10.1177\/0091270004273343"},{"key":"bibr6-IMP1488","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e3280117ca0"},{"key":"bibr7-IMP1488","unstructured":"Malawi Ministry of Health. Treatment of AIDS: guidelines for the use of antiretroviral therapy in Malawi. 1st ed. Lilongwe, Malawi: Ministry of Health 2003."},{"key":"bibr8-IMP1488","unstructured":"Working Group on Antiretroviral Therapy and Medical Management in HIV-infected Children. Guidelines for the use of antiretroviral agents in pediatric HIV infection. June 25 2003. (Accessed 31 August 2009.) Available from http:\/\/aidsinfo.nih.gov\/contentfiles\/PediatricGuidelines05252003020.pdf."},{"key":"bibr9-IMP1488","doi-asserted-by":"publisher","DOI":"10.1016\/S1570-0232(03)00224-1"},{"key":"bibr10-IMP1488","unstructured":"Office of the President and Cabinet, Republic of Malawi. Malawi HIV and AIDS monitoring report 2007. (Accessed 1 July 2009.) Available from http:\/\/data.unaids.org\/pub\/Report\/2008\/malawi_2008_country_progress_report_en.pdf."},{"key":"bibr11-IMP1488","unstructured":"WHO, UNAIDS, UNICEF. Epidemiological fact sheet on HIV and AIDS: Malawi. 2008 Update. (Accessed 1 July 2009.) Available from http:\/\/www.who.int\/globalatlas\/predefinedReports\/EFS2008\/full\/EFS2008_MW.pdf."},{"key":"bibr12-IMP1488","doi-asserted-by":"publisher","DOI":"10.1097\/01.aids.0000183625.97170.59"},{"key":"bibr13-IMP1488","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1177\/135965350701200205","volume":"12","author":"Ellis J.C.","year":"2007","journal-title":"Antivir Ther"},{"key":"bibr14-IMP1488","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1542\/peds.96.2.247","volume":"96","author":"Kline M.W.","year":"1995","journal-title":"Pediatrics"},{"key":"bibr15-IMP1488","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.44.3.590-597.2000"},{"key":"bibr16-IMP1488","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/174.4.713"},{"key":"bibr17-IMP1488","unstructured":"Malawi Ministry of Health. Treatment of AIDS: guidelines for the use of antiretroviral therapy in Malawi. 2nd ed. Lilongwe, Malawi: Ministry of Health 2006."},{"key":"bibr18-IMP1488","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e3282f4a208"}],"container-title":["Antiviral Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP1488","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP1488","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:49:17Z","timestamp":1777380557000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.3851\/IMP1488"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,1]]},"references-count":18,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2010,1]]}},"alternative-id":["10.3851\/IMP1488"],"URL":"https:\/\/doi.org\/10.3851\/imp1488","relation":{},"ISSN":["1359-6535","2040-2058"],"issn-type":[{"value":"1359-6535","type":"print"},{"value":"2040-2058","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,1]]}}}