O213 CD4-guided STI in patients responding to HAART

Methods LOTTI is a randomized, controlled, prospective trial. Patients with HIV-RNA 700 cells/mcL were randomised to continue HAART or to stop it; 350 cells/mcL was the immunologic threshold to resume HAART. The primary end-point is clinical: development of any opportunistic disease, death from any cause, or the occurrence of diseases, other than opportunistic, requiring hospital admission. Secondary endpoints are major adverse effects, virologic failures and therapeutic costs. An interim ITT analysis at 4-years follow-up is presented.