Phase I open-label study of HIV-positive individuals who received treatment from diagnosis aimed at evaluating the safety and efficacy of HIVconsv vaccines administered in combination with romidepsin for virus control after discontinuation of antiretrovir

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Phase I open-label study of HIV-positive individuals who received treatment from diagnosis aimed at evaluating the safety and efficacy of HIVconsv vaccines administered in combination with romidepsin for virus control after discontinuation of antiretroviral therapy | BCN02-Romi

04/02/2016 - 31/12/2018

Type of research: Interventional Promoter: IrsiCaixa AIDS Research Institute Principal Investigators: Beatriz Mothe, Jose Moltó Participating entities: Hospital Universitario Germans Trias i Pujol (Fundación Lucha contra el Sida), Hospital Clínic de Barcelona, BCN Checkpoint

The BCN02-Romi clinical trial is an eradication study that will evaluate the effectiveness of a  'kick and kill' strategy based on the most immunogenic therapeutic vaccines available to date (HIVconsv) in combination with the most powerful latency reactivation drug currently available (romidepsin). HIV-positive people who have been treated from diagnosis and who have previously been vaccinated in the BCN01 clinical trial represent an ideal group with which to demonstrate the efficacy of this combination in reducing the viral reservoir and in controlling viral rebound after treatment ends. By means of a populational PK/PD analysis, this study investigates the relationship between romidepsin levels and in-vivo effects on induced expression of reservoir HIV and the impact on the immune system.  The study results will enable the romidepsin dose to be optimized and will identify markers that help assess the efficacy of eradication strategies currently being studied.

  • Design: Open, multicentre
  • Phase: I
  • Sample size: 24
  • NCT02616874
  • EudraCT: 2015-002300-84

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Irsi Caixa

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