TILT: a randomized controlled trial of interruption of antiretroviral therapy with or without interleukin-2 in HIV-1 infected individuals

Abstract

The primary aim of the trial was to gain experience in using IL-2. IL-2 delayed restarting drugs and fewer new drugs were used.

Soluble mediators of inflammation in HIV and their implications for therapeutics and vaccine development

“…Despite the fact that the SMART trial showed increased incidence of clinical events with treatment interruption, there have been multiple studies investigating if IL-2 therapy in conjunction with ART interruption increased the time to restarting ART. The Therapy Interruption with and without use of Interleukin-2 (TILT) study was an early study conducted to determine if IL-2 therapy during ART would increase time before therapy restart [126]. The study results showed that after 105 weeks, patients with IL-2 therapy had a 34% chance of restarting ART compared to 66% for patients not receiving IL-2.…”

Inferiority of IL-2 alone versus IL-2 with HAART in maintaining CD4 T cell counts during HAART interruption: a randomized controlled trial

“…The recently published TILT trial demonstrated IL-2 could reduce the probability of restarting ARVs by 50% following 2 years of HAART interruption [51]. The different conclusions in ICARUS and TILT may be explained by the stricter criterion for Treatment Success used in the former.…”

“…The different conclusions in ICARUS and TILT may be explained by the stricter criterion for Treatment Success used in the former. Whereas we sought to maintain CD4 T cells within 10% of baseline levels (947 cells/µl), in TILT, IL-2 cycles were triggered by CD4 T cell counts <350 cells/µl, and HAART was restarted for CD4 T cell counts <200 cells/µl [51]. In fact, CD4 T cell increases following IL-2 plus HAART were similar in these studies, with half the HAART Interrupters in ICARUS qualifying as Treatment Successes at Month 6.…”

Immunotherapies in HIV-1 infection

“…This phase II clinical trial, with a CD4 þ T-cell endpoint, randomized HIV-infected patients with CD4 þ T cell count of more than 350 cells/ml to intermittent rIL-2 alone and intermittent rIL-2 with pericycle cART versus no therapy; results are expected in mid-2009. Last, whether the use of rIL-2 with cART followed by a treatment interruption would result in a delayed time to the reinitiation of cART compared with a treatment interruption alone [63]. In the TILT study, cART was restarted when CD4 þ cell count reached 200 cells/ml.…”