An observational study in Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare. Completed. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by ViiV Healthcare · Observational
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).
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 1 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Seven paediatric HIV cohorts participating in the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) as follows: French Perinatal Cohort Study / Enquête Périnatale Français; Hospital St.Pierre Cohort, Brussels; Italian Register for HIV-infection in Children; Madrid Cohort of HIV-infected Children; Spanish Perinatal Cohort Study [NENEXP], Catalonia, Spain; UK National Study of HIV in Pregnancy and Childhood [NSHPC] \& Collaborative HIV Paediatric Study [CHIPS]; and the "Victor Babes" Hospital Cohort, Romania.
Exclusion Criteria:
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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.
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)
Number of children on licensed dose of FPV/RTV
Time frame: Assessed at 1, 2 and 3 years post exposure
Reason for stopping FPV
Time frame: Assessed at 1, 2 and 3 years post exposure
Laboratory tests for absolute neutrophil counts (ANC), lipids (total cholesterol [TC] and triglycerides [TG]), and alanine transaminase (ALT)
Time frame: Assessed at 1, 2 and 3 years post exposure
No study locations are listed for this record.
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
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