PENTA Fosamprenavir Study

ViiV Healthcare

Status: Completed

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)

Study type: Observational

Funder types: Industry

Identifiers

NCT01077635

112880

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-1 infected children aged 6-18 years exposed to licensed paediatric dose of FPV/RTV January 1 2008 (or date of exposure to FPV if earlier to this but still exposed at 1/1/2008) from the participating cohorts

Exclusion criteria

Trial design

1 participants in 1 patient group

HIV-1 infected children aged 6 ≤ 18 years

Description:

HIV-1 infected children aged 6 ≤ 18 years currently or having ever been exposed to FPV/RTV; this is the indicated group for the licensed dose in the paediatric population.

Treatment:

Drug: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)