Multi-country, non-interventional, cohort study of the effectiveness, safety, adherence, and health-related quality of life in HIV-1 infected adult patients receiving Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF) (BIC-STaR)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40000
• EU PAS number:
  EUPAS22185
• Study ID:
  40000
• Official title and acronym:
  Multi-country, non-interventional, cohort study of the effectiveness, safety, adherence, and health-related quality of life in HIV-1 infected adult patients receiving Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF) (BIC-STaR)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Ireland

  Italy

  Netherlands

  Spain

  Türkiye

  United Kingdom
• Study description:
  GS-EU-380-4472: This non-interventional cohort study will evaluate the effectiveness, safety, adherence, resource utilization and patients’ health condition via Patient Reported Outcome (PRO) questionnaires, during treatment with B/F/TAF in routine clinical care.
• Study status:
  Ongoing

Research institution and networks

Institutions

Gilead Sciences

Study timelines

Date when funding contract was signed

Planned: 08/09/2017

Actual: 11/09/2017

Study start date

Planned: 15/06/2018

Actual: 28/06/2018

Data analysis start date

Actual: 29/03/2019

Date of final study report

Planned: 18/04/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Europe Ltd

Study protocol

Initial protocol

GS-EU-380-4472-appendix-16.1.1-protocol_f-redact

Updated protocol

GS-EU-380-4472-appendix-16.1.1-protocol amendment 4_f-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable