An Observational Drug Utilization Study of Stribild® in Adults with HIV-1 Infection

Study identification

• EU PAS number:
  EUPAS6524
• Study ID:
  24887
• Official title and acronym:
  An Observational Drug Utilization Study of Stribild® in Adults with HIV-1 Infection
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  GS-EU-236-0141: A Drug Utilisation Study to assess renal risk minimization measures among Stribild®-treated patients and factors associated with the risk of proximal renal tubulopathy, and its reversibility, including event rates.
• Study status:
  Finalised

Research institutions and networks

Institutions

St Stephen's Aids Trust

Multiple centres: 50 centres are involved in the study

Networks

NEAT-ID, The European treatment network for HIV, hepatitis and global infectious diseases

Study timelines

Date when funding contract was signed

Planned:01/04/2014

Actual:01/04/2014

Study start date

Planned:31/07/2014

Actual:04/03/2015

Date of interim report, if expected

Planned:29/01/2016

Actual:23/03/2016

Date of final study report

Planned:31/01/2017

Actual:15/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Europe Ltd

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)