Penta HIV Trials | PENTA 13

A Model-based approach to dose selection in early pediatric development

2010

Authors: Cella M, Gorter de Vries F, Burger D, Danhof M, Della Pasqua O.

Published in: Clinical Pharmacology and Therapeutics, 2010, 87(3):294-302.

Abstract The establishment of a rationale for determining dosing regimens in pediatric patients remains a challenge in drug development. In this investigation, we explored several methodologies to support bridging studies and evaluated the best descriptor of developmental changes that can be used as a covariate for dose adjustment in children.

Adherence and acceptability of once daily lamivudine and abacavir in HIV-1 infected children

2006

Authors: LeProvost M, Green H, Flynn J, et al; on behalf of the PENTA 13 study group.

Published in: Pediatr Infect Dis J. 2006;25(6):533-7

Background Data on adherence to and acceptability of once daily lamivudine and abacavir are few.

Methods Twenty-four U.K. human immunodeficiency virus type-1 infected children 2-13 years of age participated in the Pediatric European Network for the Treatment of AIDS (PENTA) 13 single arm,

Adherence and acceptability of once daily lamivudine and abacavir in HIV-1 infected children

2005

Authors: LeProvost M, Green H, Flynn J, et al: on behalf of the PENTA 13 study group.

Published in: 3rd IAS Conference on HIV Pathogenesis and Treatment, 24-27 July 2005, Rio de Janerio. Poster MoPe9.2C03

Pharmacokinetics of once versus twice daily lamivudine and abacavir. Simplification of combination treatment in HIV-1 infected children (Penta 13)

2005

Authors: Bergshoeff A, Burger D, Verweij C, et al; on behalf of the PENTA 13 study group

Published in: Antivir Ther. 2005; 10:239-246

Background There are few data on plasma and intracellular pharmacokinetics (PK) of once-daily (q24h) nucleoside analogues in HIV-infected children.

Methods Children aged 2-13 years receiving combination treatment containing lamivudine (3TC) (4 mg/kg) and/or abacavir (ABC) (8 mg/kg) twice daily (q12h) were included in this single-arm,

Pharmacokinetics (PK) of once daily versus twice daily Lamivudine and Abacavir in HIV-1 infected children: PENTA 13

2004

Authors: Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, LeProvost M, Walker AS, Novelli V, Lyall H, Gibb DM.

Published in: 11th Conference of Retroviruses and Opportunistic Infections, San Francisco, 8-11 February 2004. Poster 934.

1