Prospective Non-Interventional Real-Life Study of Effectiveness, Safety, Adherence, and Health-Related Quality of Life in Adult Patients receiving Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide (E/C/F/TAF) or Rilpivirine/Emtricitabine/Tenofovir alafenamide (R/F/TAF) for HIV-1 Infection in France (TARANIS)

Study identification

• EU PAS number:
  EUPAS16212
• Study ID:
  46011
• Official title and acronym:
  Prospective Non-Interventional Real-Life Study of Effectiveness, Safety, Adherence, and Health-Related Quality of Life in Adult Patients receiving Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide (E/C/F/TAF) or Rilpivirine/Emtricitabine/Tenofovir alafenamide (R/F/TAF) for HIV-1 Infection in France (TARANIS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  GS-FR-292-4043: This study aimed to describe the effectiveness and safety of E/C/F/TAF and R/F/TAF in treatment-naive and treatment-experienced HIV-1 infected adults as well as adherence, resource utilization, patient reported outcome data about quality of life, health status and treatment satisfaction during daily routine use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 38 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 28/03/2016

Actual: 28/03/2016

Study start date

Planned: 03/04/2017

Actual: 13/04/2017

Data analysis start date

Planned: 14/09/2020

Actual: 02/03/2021

Date of interim report, if expected

Planned: 18/06/2018

Actual: 02/07/2018

Date of final study report

Planned: 31/12/2021

Actual: 20/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Regulatory

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