NCT01077635

PENTA Fosamprenavir Study

An Observational Multi-cohort Study on the Use of Fosamprenavir-Ritonavir Among HIV-infected Children and Adolescents in Europe

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)	HIV-1 infected children currently or having ever been exposed to FPV (+/- 20% of 18mg/kg BID + RTV)

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-03-01
• Last updated: 2017-06-01