PENTA Fosamprenavir Study
| Tracking Information | |||||
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| First Received Date ICMJE | February 25, 2010 | ||||
| Last Updated Date | February 2, 2012 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of children on licensed dose of FPV/RTV [ Time Frame: Assessed at 1, 2 and 3 years post exposure ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01077635 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | PENTA Fosamprenavir Study | ||||
| Official Title ICMJE | An Observational Multi-cohort Study on the Use of Fosamprenavir-Ritonavir Among HIV-infected Children and Adolescents in Europe | ||||
| Brief 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). |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | 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. |
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| Condition ICMJE | Infection, Human Immunodeficiency Virus | ||||
| Intervention ICMJE | 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) |
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| Study Group/Cohort (s) | HIV-1 infected children aged 6 ≤ 18 years
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.
Intervention: Drug: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - |
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| Gender | Both | ||||
| Ages | 6 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01077635 | ||||
| Other Study ID Numbers ICMJE | 112880 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||||
| Study Sponsor ICMJE | ViiV Healthcare | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | ViiV Healthcare | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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