PENTA Fosamprenavir Study

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01077635
First received: February 25, 2010
Last updated: February 2, 2012
Last verified: January 2012
  Purpose

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 Intervention
Infection, Human Immunodeficiency Virus
Drug: Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Reason for stopping FPV [ Time Frame: Assessed at 1, 2 and 3 years post exposure ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: October 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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)

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077635

Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01077635     History of Changes
Other Study ID Numbers: 112880
Study First Received: February 25, 2010
Last Updated: February 2, 2012
Health Authority: United Kingdom: No Health Authority

Keywords provided by ViiV Healthcare:
HIV
Antiretroviral therapy
protease inbitor
fosamprenavir
paediatrics

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Fosamprenavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014