A Comprehensive Assessment of Adverse Events and Overall Safety Profile in HIV Positive Patients Treated with Dolutegravir as Compared to Other Integrase Strand Transfer Inhibitors or Darunavir (207832)

Study identification

• EU PAS number:
  EUPAS22231
• Study ID:
  42164
• Official title and acronym:
  A Comprehensive Assessment of Adverse Events and Overall Safety Profile in HIV Positive Patients Treated with Dolutegravir as Compared to Other Integrase Strand Transfer Inhibitors or Darunavir (207832)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned:06/12/2017

Actual:06/12/2017

Study start date

Planned:08/01/2018

Actual:12/01/2018

Date of final study report

Planned:29/11/2019

Actual:04/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Regulatory

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