An Observational, Drug Utilization Study of Viread® in Children and Adolescents with HIV-1 Infection (GS-EU-104-0433)

Study identification

• EU PAS number:
  EUPAS7814
• Study ID:
  24997
• Official title and acronym:
  An Observational, Drug Utilization Study of Viread® in Children and Adolescents with HIV-1 Infection (GS-EU-104-0433)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Germany

  Ireland

  Italy

  Netherlands

  Poland

  Portugal

  Romania

  Spain

  Sweden

  United Kingdom
• Study description:
  GS-EU-104-0433: On 22 November 2012 the European Commission adopted a Decision on applications to extend the indications for Viread to include children and adolescent patients with HIV-1 infection aged 2 to <18 years and adolescents with chronic hepatitis B (CHB) infection aged 12 to <18 years.In Europe, several established, prospective observational cohort studies of HIV-1 infected children and adolescents participate in the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC). Gilead Sciences have initiated collaboration with EPPICC to design a Drug Utilization Study using these cohorts of HIV-1 infected children living in the EU.The rationale for this study was to assess characteristics of patients treated with Viread® prior to and following the approval of the pediatric indication on 22 November 2012, and to assess how physicians are prescribing Viread® to children and adolescents, including off-label use, in order to determine the effectiveness of the risk minimization measures i.e. the SmPC, which have been implemented subsequent to approval.In addition, the study assessed the characteristics of all children and adolescents receiving tenofovir disoproxil fumarate (TDF)-based regimens at or after the Viread approval date.
• Study status:
  Finalised

Research institutions and networks

Institutions

Friberg Research AB

Multiple centres: 50 centres are involved in the study

Networks

EPPICC

Study timelines

Date when funding contract was signed

Planned:31/10/2014

Actual:30/04/2015

Study start date

Planned:31/01/2015

Actual:31/01/2015

Data analysis start date

Planned:01/09/2015

Actual:01/09/2015

Date of interim report, if expected

Planned:31/12/2015

Actual:31/12/2015

Date of final study report

Planned:31/12/2017

Actual:21/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences, Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)