Real-life study of single tablet regimen (STR) and multi tablet regimen (MTR) usage in Germany on persistency of initial therapy - STRingent

Study identification

• EU PAS number:
  EUPAS6118
• Study ID:
  16940
• Official title and acronym:
  Real-life study of single tablet regimen (STR) and multi tablet regimen (MTR) usage in Germany on persistency of initial therapy - STRingent
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This non-interventional trial will enroll 1000 patients, who are antiretroviral therapy naive, HIV-1 infected and initiate their first anti HIV treatment. There will be 500 patients in each arm (STR-arm and MTR-arm), each patient shall be documented for 12 months. Main objective is therapy persistency compared between STR and MTR. Additionally the study will collect data on laboratory parameters, adherence, quality of life, and adverse drug reactions.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 41 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned:26/02/2014

Actual:26/02/2014

Study start date

Planned:30/04/2014

Actual:19/05/2014

Data analysis start date

Planned:20/07/2016

Actual:21/04/2016

Date of final study report

Planned:21/04/2017

Actual:08/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences GmbH

Regulatory

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