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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).
Observational Model: Cohort, Time Perspective: Prospective
Infection, Human Immunodeficiency Virus
Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:15:35-0400
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Proteins encoded by the TAT GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Proteins encoded by the NEF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Proteins encoded by the VIF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Proteins encoded by the REV GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Proteins encoded by the VPR GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...