Rates of Suspected Hypersensitivity Reaction in HIV infected Adult treatment populations screened HLA-B*5701 negative prior to commencing Abacavir therapy: Meta-analysis of Data from GlaxoSmithKline and ViiV Healthcare Sponsored Clinical Trials (207831)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42161
• EU PAS number:
  EUPAS18543
• Study ID:
  42161
• Official title and acronym:
  Rates of Suspected Hypersensitivity Reaction in HIV infected Adult treatment populations screened HLA-B*5701 negative prior to commencing Abacavir therapy: Meta-analysis of Data from GlaxoSmithKline and ViiV Healthcare Sponsored Clinical Trials (207831)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A meta-analysis of data previously collected for 12 MAH- sponsored randomized clinical trials (RCTs) from Phase IIb–IV of drug development, conducted since January 2007. Three thousand and sixty three HLA¬B*5701 negative, HIV infected Adult Subjects were exposed to regimens that included abacavir for a minimum of 20 Weeks, as part of these RCTs. In a sub-population of seven of these RCTs, 1,494 such subjects were exposed to either TRIUMEQ, or its equivalent component actives (given as the single active preparation of TIVICAY in combination with KIVEXA), for a minimum of 24 Weeks. Incidence rates of both: Investigator diagnosed, and MAH adjudicated, clinically suspected abacavir hypersensitivity reactions will be estimated. The exposure to an abacavir-containing regimen will be reported. 95% CIs will be based on exact binomial 2-sided confidence intervals. These analyses will be repeated in the sub-population of subjects, who received TRIUMEQ or its equivalent component actives.
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 31/03/2017

Actual: 23/03/2017

Study start date

Planned: 10/04/2017

Actual: 10/04/2017

Data analysis start date

Planned: 10/04/2017

Actual: 10/04/2017

Date of final study report

Planned: 26/06/2018

Actual: 19/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

viiv-207831-protocol-redact

Regulatory

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