Dolutegravir Use and Predictors of CNS events: Meta-analysis of Data from Phase III/IIIb Clinical Trials

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48229
• EU PAS number:
  EUPAS26866
• Study ID:
  48229
• Official title and acronym:
  Dolutegravir Use and Predictors of CNS events: Meta-analysis of Data from Phase III/IIIb Clinical Trials
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Belgium

  Brazil

  Canada

  Chile

  Denmark

  France

  Germany

  Greece

  Hungary

  Italy

  Mexico

  Netherlands

  Portugal

  Puerto Rico

  Romania

  Russian Federation

  South Africa

  Spain

  Switzerland

  Taiwan

  Thailand

  United Kingdom

  United States
• Study description:
  This study is a meta-analysis of dolutegravir studies that included data that were previously collected for VH-sponsored clinical trials in adult Phase III/IIIb of drug development for dolutegravir. Studies included in the meta-analysis are Spring 2, Single, Flamingo, Aria and Sailing. The primary objective was to assess if there are any variables associated with the development of a Neuropsychiatric Symptom(NP) during the course of the trials. The incidence of NP events was calculated from frequencies of reported adverse events in the included clinical trials, 95% CIs are based on exact binomial 2-sided CIs. To assess the effect of pre-specified variables associated with the exposure adjusted incidence rate and relative rate of NP events in HIV patients treated with DTG containing versus non DTG containing regimens as well as DTG + ABC exposure vs DTG + other regimens Poisson mixed effects meta-regression models was used. 95% CIs were calculated for rates and relative rates.
• Study status:
  Finalised

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Planned: 29/06/2018

Actual: 25/05/2017

Study start date

Actual: 26/05/2017

Date of final study report

Actual: 30/09/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

viiv-207953-protocol-redact

Regulatory

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