PENTA Fosamprenavir Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01077635 |
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Recruitment Status
:
Completed
First Posted
: March 1, 2010
Last Update Posted
: June 1, 2017
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Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
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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).
| Condition or disease | Intervention/treatment |
|---|---|
| Infection, Human Immunodeficiency Virus | Drug: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV) |
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
| Study Type : | Observational |
| Actual Enrollment : | 1 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | An Observational Multi-cohort Study on the Use of Fosamprenavir-Ritonavir Among HIV-infected Children and Adolescents in Europe |
| Study Start Date : | October 2008 |
| Actual Primary Completion Date : | September 2011 |
| Actual Study Completion Date : | September 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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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Primary Outcome Measures
:
- Number of children on licensed dose of FPV/RTV [ Time Frame: Assessed at 1, 2 and 3 years post exposure ]
Secondary Outcome Measures
:
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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:
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077635
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | ViiV Healthcare |
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT01077635 History of Changes |
| Other Study ID Numbers: |
112880 |
| First Posted: | March 1, 2010 Key Record Dates |
| Last Update Posted: | June 1, 2017 |
| Last Verified: | January 2012 |
Keywords provided by ViiV Healthcare:
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HIV Antiretroviral therapy protease inbitor fosamprenavir paediatrics |
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Fosamprenavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |