Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated
for the treatment of HIV-infected adults, adolescents and children of 6 years of age and
above for use in combination with other anti-HIV medicines. Safety data from two
GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or
without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated
that gastrointestinal events were the most commonly reported AEs, but that the majority of
events were mild and of short duration. Treatment emergent grade 3 / 4 neutropenia was
reported in 20% of children in the APV20003 trial; and neutropenia was identified as a
potential safety concern by the European Medicines Agency (EMEA). The objectives of this
study were to conduct an observational cohort study of the usage and safety of FPV/RTV in
children and adolescents (aged 6 ≤ 18 years) with HIV infection in several European HIV
paediatric cohorts. Data will be collected for 3 years (2008, 2009 and 2010).