The study, which has enrolled a total of 31 returning patients from a previous trial and 54 new patients, will examine IR103, a second generation immunotherapy, as a first-line treatment for drug-naive HIV-infected individuals not yet recommended for antiretroviral therapy according to current medical guidelines.
In addition, approval has been obtained for expansion of the study to include an additional 50 patients, and enrollment of the additional patients has begun. Ultimately over 200 drug-naive patients will be enrolled in two parallel studies with sites in Italy, France, Canada and the UK.
The study is designed to assess the safety and ability of various doses of IR103 to induce HIV-specific immunity.
The trial will also measure changes in CD4+ counts, a critical marker of HIV disease progression that is used, along with viral load, to determine when a patient should begin antiretroviral therapy. The company believes an immune-based therapy that stabilizes CD4+ counts could be used to delay initiation of antiretroviral therapy and serve as an important advance in the treatment of HIV.
“We are very encouraged by the rapid recruitment of patients in Italy in the IR103 study,” said Dr Georgia Theofan, vice president of clinical development. “We are looking forward to the expansion and enrollment of additional patients in Europe as we continue generating data on our second generation immune-based therapy for HIV in this important patient population.”