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news.Objectif Recherche VACcin Sida (ORVACS) has launched a Phase II study, called Eramune 01, designed to test the hypotheses that combination therapy with antiviral agents and immunomodulator can lead to a decrease in the HIV viral reservoirs and, ultimately, to eradication of the virus.
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The Eramune 01 study is an international, multicenter, randomised, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV-infected patients with long-term viral suppression.
Eramune 01 will use Cytheris’ investigative immunomodulatory agent, recombinant human interleukin-7 (CYT107), in combination with two potent antiretroviral drugs represented by the integrase inhibitor, raltegravir (Isentress – Merck) and the CCR5 inhibitor, maraviroc (Selzentry – ViiV Healthcare).
ORVACS said that the main hypothesis of this study is that by combining the most potent and synergistic antiretroviral drugs, coupled with an immunomodulating agent capable of targeting or inducing activation of latently infected cells, the reservoirs of HIV can be decreased and, in the best case scenario, eradication of the virus may be feasible.
Principal investigator of the study Christine Katlama said that the novelty of the approach in this study is three-fold.
"First, the use of potent antiretroviral therapy combining drugs with different HIV enzyme targets or receptors and different penetrations in cells, to suppress the virus to truly undetectable levels; secondly, the addition of immunomodulatory therapy that specifically targets viral reservoirs; and lastly, the rigorous selection of patients already having a low HIV reservoir as measured by peripheral blood HIV DNA content," Katlama said.