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Kamya MR Mayanja-Kizza H Kambugu A Bakeera-Kitaka S Semitala F Mwebaze-Songa P Castelnuovo B Schaefer P Spacek LA Gasasira AF Katabira E Colebunders R Quinn TC Ronald A Thomas DL Kekitiinwa A;Academic Alliance for AIDS Care Prevention in Africa 《Journal of acquired immune deficiency syndromes (1999)》2007,46(2):187-193
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Kasirye P Kendall L Adkison KK Tumusiime C Ssenyonga M Bakeera-Kitaka S Nahirya-Ntege P Mhute T Kekitiinwa A Snowden W Burger DM Gibb DM Walker AS;ARROW Trial Team 《Clinical pharmacology and therapeutics》2012,91(2):272-280
The bioequivalence of formulations is usually evaluated in healthy adult volunteers. In our study in 19 HIV-1-infected Ugandan children (1.8-4 years of age, weight 12 to <15 kg) receiving zidovudine, lamivudine, and abacavir solutions twice a day for ≥24 weeks, the use of scored tablets allowed comparison of plasma pharmacokinetics of oral solutions vs. tablets. Samples were collected 0, 1, 2, 4, 6, 8, and 12 h after each child's last morning dose of oral solution before changing to scored tablets of Combivir (coformulated zidovudine + lamivudine) and abacavir; this was repeated 4 weeks later. Dose-normalized area under curve (AUC)(0-12) and peak concentration (C(max)) for the tablet formulation were bioequivalent with those of the oral solution with respect to zidovudine and abacavir (e.g., dose-normalized geometric mean ratio (dnGMR) (tablet:solution) for zidovudine and abacavir AUC(0-12) were 1.01 (90% confidence interval (CI) 0.87-1.18) and 0.96 (0.83-1.12), respectively). However, lamivudine exposure was ~55% higher with the tablet formulation (AUC(0-12) dnGMR = 1.58 (1.37-1.81), C(max) dnGMR = 1.55 (1.33-1.81)). Although the clinical relevance of this finding is unclear, it highlights the impact of the formulation and the importance of conducting bioequivalence studies in target pediatric populations. 相似文献
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Nahirya-Ntege P Musiime V Naidoo B Bakeera-Kitaka S Nathoo K Munderi P Mugyenyi P Kekitiinwa A Bwakura-Dangarembizi MF Crawley J;ARROW Trial Team 《The Pediatric infectious disease journal》2011,30(6):535-537
Hypersensitivity reactions are reported in approximately 5% of adults receiving abacavir, but there are few published data in children. Among 1150 African children receiving antiretroviral therapy in a randomized trial, suspected hypersensitivity reactions to abacavir were rare (0.3%; 95% CI, 0.01-0.9). Patients were managed successfully through the provision of clear guidelines and education of clinical staff, children, and their caregivers. 相似文献