Cytheris has initiated a Phase II clinical study of investigative immunomodulatory agent CYT107 (rhIL-7) for the treatment of HIV, in combination with antiretroviral drugs raltegravir (Isentress) and maraviroc (Selzentry).
The study aims to combine the most potent and synergistic antiretroviral drugs with an immunomodulating agent to decrease the reservoirs of HIV and, in the best-case scenario, to eradicate the virus.
The randomised, multicentre, international, controlled and non-comparative study will enrol 28 HIV-infected patients with long-term viral suppression, and will be conducted at clinical sites in France, Spain, Italy and the UK.
The patients will be randomised in an open label, non-blinded manner into two treatment arms, with 14 patients in each arm.
The first arm will receive antiretroviral intensification (cART plus raltegravir and maraviroc), while the second arm will receive antiretroviral intensification plus immunomodulatory intervention.
The primary objective of the study is a decrease in the HIV-1 viral reservoir.
The secondary objectives are to describe the immunologic effects of treatment intensification, develop a model for HIV DNA decay in patients receiving treatment intensification, determine the safety of treatment intensification and to eradicate HIV in the lymphoid reservoirs of HIV in the gut.