A chewable pediatric fixed-dose combination tablet of stavudine, lamivudine, and nevirapine: pharmacokinetics and safety compared with the individual liquid formulations in human immunodeficiency virus-infected children in Thailand

Vanprapar, N.; Cressey, T. R.; Chokephaibulkit, K.; Muresan, P.; Plipat, N.; Sirisanthana, V.; Prasitsuebsai, W.; Hongsiriwan, S.; Chotpitayasunondh, T.; Eksaengsri, A.; Toye, M.; Smith, M. E.; McIntosh, K.; Capparelli, E.; Yogev, R.

Pediatr Infect Dis J. 2010 May 11; 29(10):940-4

Abstract

BACKGROUND: Pediatric fixed-dose combinations (FDCs) are needed to facilitate antiretroviral therapy in children. We evaluated the relative bioavailability, safety, and therapeutic adequacy of a novel chewable pediatric FDC tablet of stavudine (7 mg), lamivudine (30 mg), and nevirapine (50 mg), referred to as GPO-VIR S7, and compared it with the individual original brand-name liquid formulations in human immunodeficiency virus-infected Thai children. METHODS: The International Maternal Pediatric Adolescent AIDS Clinical Trials group (IMPAACT) P1056 study was a phase I/II, 2-arm, randomized, open-label, multidose pharmacokinetic cross-over study. Children >/=6 to

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