Rates of Suspected Hypersensitivity Reaction to Abacavir and Associated Rates of HLA-B*5701 Testing (206206)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42114
• EU PAS number:
  EUPAS14290
• Study ID:
  42114
• Official title and acronym:
  Rates of Suspected Hypersensitivity Reaction to Abacavir and Associated Rates of HLA-B*5701 Testing (206206)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Rates of suspected hypersensitivity reaction (HSR) associated with the use of abacavir (ABC) and associated rates of HLA-B*5701 testing in HIV positive patients living in the U.S. who have been exposed to ABC as part of an antiretroviral therapy (ART) regimen will be evaluated utilizing prospectively-collected electronic medical record (EMR) data obtained from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA®) Observational Database
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 14/06/2016

Actual: 14/06/2016

Study start date

Planned: 29/07/2016

Actual: 23/07/2016

Data analysis start date

Planned: 29/07/2016

Actual: 23/07/2016

Date of final study report

Planned: 30/03/2018

Actual: 30/05/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

viiv-206206-protocol-redact

Regulatory

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