Previous presentation: This work is not being submitted elsewhere. Intermediate analyses were presented at IAS 2011 (Rome) and final analyses at ESPID 2012 (Thessaloniki).
Post-licensing safety of fosamprenavir in HIV-infected children in Europe†
Article first published online: 25 NOV 2013
© 2013 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
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Pharmacoepidemiology and Drug Safety
Volume 23, Issue 3, pages 321–325, March 2014
How to Cite
Judd, A., Duong, T., Galli, L., Goetghebuer, T., Ene, L., Julian, A. N., Amador, J. T. R., Pimenta, J. M., Thorne, C., Giaquinto, C. and on behalf of the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord (2014), Post-licensing safety of fosamprenavir in HIV-infected children in Europe. Pharmacoepidem. Drug Safe., 23: 321–325. doi: 10.1002/pds.3543
- Issue published online: 4 MAR 2014
- Article first published online: 25 NOV 2013
- Manuscript Accepted: 17 OCT 2013
- Manuscript Revised: 28 AUG 2013
- Manuscript Received: 8 APR 2013
- European Union Seventh Framework Programme. Grant Number: 260694
- 1Safety and antiviral activity of fosamprenavir/ritonavir once daily regimens in HIV-infected paediatric subjects ages 2 to 18 years (48-week interim data, study APV20003). In 14th Conference on Retroviruses and Opportunistic Infections 2007. Los Angeles., et al.
- 22012. Washington, DC. Abstract TUAB0202., et al. Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV-positive four weeks to <two year-old children (48-week data, study APV20002, a prospective, open-label, multi-centre, 48-week cohort study). In 19th International AIDS Conference (IAC)
- 3Pharmacokinetics, safety and antiviral activity of fosamprenavir-containing regimens in HIV-positive 2 to 18 year-old children (48-week data, Study APV29005, a prospective, open-label, multi-centre, 48-week cohort study). in 19th International AIDS Conference (IAC). 2012. Washington, DC. Abstract no. MOPE049., et al.
- 4GSK Clinical Study Register, Available at: http://www.gsk-clinicalstudyregister.com/index.jsp.
- 5Long-term efficacy and safety of fosamprenavir in human immunodeficiency virus-infected pediatric patients. Pediatr Infect Dis J 2010; 29(6): 563–566., et al.,
- 6Developing a multidisciplinary network for clinical research on HIV infection: the EuroCoord experience. Clinical Investigation 2012; 2: 255–264., et al.,
- 7Division of AIDS, Division of AIDS table for grading the severity of adult and pediatric adverse events. Version 1.0, December 2004; clarification August 2009, Bethesda, MD: National Institutes of Health.
- 8Anon, Antiretroviral treatment of HIV infection—updated Swedish recommendations 2009. Information from the Swedish Medical Product Agency, 2011; 3: 8–35 (Article in Swedish).