GS-EU-276-4027: A Cross Sectional Post Authorization Safety Study to Assess Healthcare Provider’s Level of Awareness of Risk Minimisation Materials for Truvada® for Pre Exposure Prophylaxis in the European Union

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26881
• EU PAS number:
  EUPAS19479
• Study ID:
  26881
• Official title and acronym:
  GS-EU-276-4027: A Cross Sectional Post Authorization Safety Study to Assess Healthcare Provider’s Level of Awareness of Risk Minimisation Materials for Truvada® for Pre Exposure Prophylaxis in the European Union
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Ireland

  Netherlands

  Norway

  United Kingdom
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 30/08/2016

Actual: 30/08/2016

Study start date

Planned: 31/07/2017

Actual: 04/10/2017

Date of interim report, if expected

Planned: 30/11/2017

Actual: 30/11/2017

Date of final study report

Planned: 28/09/2018

Actual: 22/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Europe Ltd

Study protocol

Initial protocol

amd-1.2-prot-GS-EU-276-4027

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)