04/02/2016 - 31/12/2018
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.