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dc.contributor.authorKulkanya Chokephaibulkiten_US
dc.contributor.authorTim R. Cresseyen_US
dc.contributor.authorEdmund Capparellien_US
dc.contributor.authorVirat Sirisanthanaen_US
dc.contributor.authorPetronella Muresanen_US
dc.contributor.authorSuchat Hongsiriwonen_US
dc.contributor.authorChaiwat Ngampiyaskulen_US
dc.contributor.authorChanin Limwongseen_US
dc.contributor.authorOrasri Wittawatmongkolen_US
dc.contributor.authorLinda Aurpibulen_US
dc.contributor.authorBill Kabaten_US
dc.contributor.authorMari Pat Toyeen_US
dc.contributor.authorMary Elizabeth Smithen_US
dc.contributor.authorAchara Eksaengsrien_US
dc.contributor.authorKenneth McIntoshen_US
dc.contributor.authorRam Yogeven_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherChiang Mai Universityen_US
dc.contributor.otherHarvard School of Public Healthen_US
dc.contributor.otherIRD Institut de Recherche pour le Developpementen_US
dc.contributor.otherUniversity of California, San Diegoen_US
dc.contributor.otherChonburi Regional Hospitalen_US
dc.contributor.otherPrapokklao Hospitalen_US
dc.contributor.otherAnn & Robert H. Lurie Children's Hospital of Chicagoen_US
dc.contributor.otherBaystate Medical Centeren_US
dc.contributor.otherNational Institute of Allergy and Infectious Diseasesen_US
dc.contributor.otherThailand Government Pharmaceutical Organizationen_US
dc.contributor.otherChildren's Hospital Bostonen_US
dc.identifier.citationAntiviral Therapy. Vol.16, No.8 (2011), 1287-1295en_US
dc.description.abstractBackground: Alternatives to the available stavudine-containing paediatric fixed-dose combination (FDC) tablets are rapidly needed due to concerns regarding the cumulative toxicity of long-term stavudine exposure. We report the bioavailability and short-term safety of a novel paediatric FDC tablet of zidovudine (ZDV)/lamivudine (3TC)/nevirapine (NVP; 30/15/28 mg) in HIV-infected children. Methods: In this Phase I/II open-label pharmacokinetic study, 42 children weighing 6-30 kg treated with NVP-based HAART for ≥4 weeks were randomized to receive the FDC tablets (GPO-VIR Z30) or the liquid formulations. Dosing was weight-based. Intensive 12-h blood sampling was performed after 2 weeks; subjects then crossed-over to the alternate formulation at equal doses and sampling repeated 2 weeks later. Pharmacokinetic parameters were determined by non-compartmental analysis. Buccal-swab samples were collected for cytochrome P450 (CYP)2B6 polymorphism analysis. Results: With the FDC tablet, the geometric mean (90% CI) area under the curve (AUC) for ZDV, 3TC and NVP was 1.58 (1.49-1.68), 7.78 (7.38-8.19) and 68.88 (62.13-76.36) μg·h/ml, respectively. Rules for NVP therapeutic inadequacy were defined a priori, and despite lower NVP exposure with the tablet (P < 0.001), the levels remained therapeutically adequate. ZDV AUC was similar between formulations. 3TC exposure was significantly higher with the tablet but comparable to historical data in adults and children taking branded tablets. While receiving the tablet, NVP AUC in children with CYP2B 516 GG (45%), GT (45%) and TT (10%) genotypes were 67.0, 74.5 and 106.4 μg·h/ml, respectively (P=0.04). Conclusions: Disparities in drug exposure between formulations were observed; however, the FDC tablet delivered therapeutically adequate exposures of each drug and could well play an important role in simplifying antiretroviral treatment for children. ©2011 International Medical Press.en_US
dc.rightsMahidol Universityen_US
dc.subjectPharmacology, Toxicology and Pharmaceuticsen_US
dc.titlePharmacokinetics and safety of a new paediatric fixed-dose combination of zidovudine/lamivudine/nevirapine in HIV-infected childrenen_US
Appears in Collections:Scopus 2011-2015

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