The REDUC study

The REDUC study was started in March 2014. The aim was to investigate the effect of a medicament against cancer called Romidepsin in combination with a HIV vaccine in well-treated HIV patients.

Romidepsin is a histone deacetylase inhibitor that has been approved as a treatment against a certain type of lymph cancer called peripheral T-cell lymphoma, where the infected cells are the same as in HIV. Therefore we found it reasonable to investigate if Romidepsin also has an effect on T-cells infected with HIV.

The treatment of HIV today is so effective that it is impossible to detect the virus in the blood. Even so, this doesn’t mean that the virus has been eradicated. HIV still ‘hides’ in the immune cells, and the virus will be reactivated as soon as the treatment is interrupted. Virus hiding in the latent infected cells is known to be the primary challenge in curing HIV.

The REDUC study is based on the “Kick and Kill” strategy: First HIV is reactivated and made visible in the latent infected cells. Romidepsin has shown to be a very effective activator of the latent HIV, and is therefore used in this first step. Second the immune system has to eradicate the virus. This step is done with the help from the HIV vaccine.

Method:

The REDUC study is divided in a Part A and a Part B.

Part A was a pilot study that ran from March till June 2014. 6 well-treated patients received 3 infusions with Romidepsin with an interval of 7 days. Afterwards we measured the viral load both in the cells and in plasma.

Part B was started in June 2014 with 20 other well-treated HIV patients. First they received 6 HIV vaccines to help the immune cells recognize the virus-producing cells and create a stronger immune response. Second they received 3 infusions with Romidepsin with an interval of 7 days like the patients in Part A.

Finally the HIV treatment is interrupted, and it is possible to measure the load of virus that is left in the body, and how many infected cells the immune system is able to eradicate.

Results:

The results from Part A were surprisingly positive and have caused international sensation. After the treatment with Romidepsin the viral load in both cells and plasma increased to a level, where it was possible to detect it with the standard measurement methods that are being used in the clinic. This has never happened in HIV research before, and it proves, that Romidepsin is a very potent reactivator of the latent virus.

Part B is expected to be finished in June 2015, after which the many tests must be evaluated. We there expect to be able to present the results from the REDUC study in the fourth quarter of 2015.

Contact:

Senior researcher: 
Læge, PhD Ole Schmeltz Søgaard
Mail: olesoega@rm.dk
Tlf: 78 45 28 42

Manager of Q research:
M.Sc., ph.d Martin Tolstrup
Mail: marttols@rm.dk
Tlf: 78 45 28 43