A Prospective Observational Cohort Study to Monitor and Compare the Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving Dolutegravir (with and without Abacavir) or other Integrase Inhibitors (with or without Abacavir) (201177)

Study identification

• EU PAS number:
  EUPAS7597
• Study ID:
  36277
• Official title and acronym:
  A Prospective Observational Cohort Study to Monitor and Compare the Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving Dolutegravir (with and without Abacavir) or other Integrase Inhibitors (with or without Abacavir) (201177)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  United Kingdom
• Study description:
  This is a five year-long non-interventional, prospective cohort study nested within the EuroSIDA study, a prospective observational cohort study of more than 18,200 patients followed in 107 hospitals in 31 European countries, plus Israel and Argentina. The study population will include HIV positive patients over the age of 16 years from EuroSIDA clinical sites, who are new users of dolutegravir (DTG) or other integrase inhibitors with and without abacavir (ABC). Following initiation of DTG with ABC based antiretroviral regimen (DTG as Triumeqä, the fixed dose combination of DTG/ABC/lamivudine) or DTG without ABC ( DTG as Tivicayä) or regimens containing other integrase inhibitors raltegravir (RAL), elvitegravir (EGV) with or without ABC, the study will aim to a) Monitor and compare hypersensitivity reaction, b) Monitor and compare hepatotoxicity, and c) Monitor and compare severe skin rash among all patients discontinuing DTG or other integrase inhibitor regimens for any reason.
• Study status:
  Finalised

Research institutions and networks

Institutions

EuroSIDA

Networks

EuroSIDA

Study timelines

Date when funding contract was signed

Planned: 30/09/2014

Actual: 30/09/2014

Study start date

Planned: 30/09/2014

Actual: 30/09/2014

Date of interim report, if expected

Actual: 22/01/2016

Date of final study report

Planned: 30/04/2020

Actual: 01/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

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)