To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of ALT-803 in HIV
This is an open-label, single-arm intra-patient dose escalating pilot study of ALT-803, a recombinant human super agonist interleukin-15 (IL-15) complex with an expansion cohort at the maximum tolerated dose (MTD). The primary aim is to investigate the safety and tolerability of ALT-803 in HIV-infected people receiving potent and optimized antiretroviral therapy. All infusions will occur on a Monday. Subjects will be monitored for 24 hours after the first infusion and then for 6 hours after each subsequent infusion, provided no unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Interleukin 15 (IL-15) is a common γ-chain cytokine that is related to interleukin-2 (IL-2) and is a critical factor for the development, proliferation, and activation of effector natural killer (NK) and CD8+ memory T cells
University of Minnesota
Minneapolis, Minnesota, United States
Assess the safety and tolerability of ALT-803 in HIV-infected subjects
Safety and tolerability is determined by the incidence of adverse events, size of the inducible reservoir as estimated using the TILDA assay
Time frame: 4 weeks
Assess the impact of ALT-803 on the size of the inducible reservoir,
Assess the impact of ALT-803 on the size of the inducible reservoir, as estimated using the TILDA assay, in total CD4+ T cells and memory subsets
Time frame: 4 weeks
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