A Prospective, Observational Drug Utilization Study of Cobicistat in Adults with HIV-1 Infection (GS-US-216-1230)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15135
• EU PAS number:
  EUPAS7470
• Study ID:
  15135
• Official title and acronym:
  A Prospective, Observational Drug Utilization Study of Cobicistat in Adults with HIV-1 Infection (GS-US-216-1230)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  Finland

  Germany

  Iceland

  Ireland

  Netherlands

  Norway

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  Study was not feasible due to low uptake of COBI and therefore was waived - Study cancelled.As part of the COBI EU-RMP, this observational drug utilization study was planned 1) to investigate the effectiveness of routine risk minimization measures by determining the rate of use to boost PIs other than ATV or DRV once-daily and concurrent use with contraindicated medications, and the outcomes of such use, and 2) to obtain information on potential drug interactions with COBI
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Gilead Sciences International Ltd

Multiple centres

Study timelines

Date when funding contract was signed

Planned: 30/06/2014

Actual: 21/07/2016

Study start date

Planned: 29/07/2016

Actual: 21/07/2016

Data analysis start date

Planned: 29/07/2018

Actual: 21/07/2016

Date of final study report

Planned: 30/12/2018

Actual: 21/07/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences International Ltd

Study protocol

Initial protocol

GS-US-216-1230 Final Draft 12Sep2014

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)

Other study registration identification numbers and links

Study was waived due to being unfeasible. Study Cancelled