ACCELEVIR DIAGNOSTICS LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Project Summary AbstractHuman immunodeficiency virus typeHIVis a retrovirus that infects CDT cells of the immune systemIf left untreatedHIVinfected individuals will progress to AIDS and may ultimately die as a resultCombination antiretroviral therapy is extremely effective at stopping the replication of HIVin infected individualsDespite the success of this therapy at suppressing HIVreplication to clinically undetectable levelsantiretroviral therapy is not curativeThis is due to the persistence of HIVin a silentor latentstate within a subset of CDT cells known as resting memory CDT cellsIn this latent statethese infected cells are not targeted by antiretroviral drugs and cannot be eliminated by the immune systemIn HIVinfected individualslatently infected CDT cells are found at extremely low frequenciesper million resting memory CDT cellswith the majority found within immune tissues at any given timeThis population of latently infected cells is very stabledemanding that HIVinfected individuals remain on antiretroviral therapy indefinitely to avoid rebound of viremiaAs suchthis population of latently infected CDT cells is the main barrier to curing HIVinfectionDeveloping strategies to eliminate latently infected cells is a major focus of the NIHNIAIDand the HIVresearch fieldTo demonstrate the efficacy of therapeutics targeting the latent reservoirwe must be able to measure the frequency of latently infected cells using rapid and accurate assays that can be scaled for widespread clinical use in both peripheral blood and immune tissuesAccelevir DiagnosticsLLC is therefore developing a new molecular assay to accurately measure the size of the latent reservoir in immune tissues from HIVinfected individualsBroadlythis proposal aims to develop and optimize our novel assay to measure latent HIVin unfractionated tissuesqualify this assaydefine the frequency and dynamics of latent HIVin immune tissue as compared to bloodand demonstrate the potential utility of our assay use previously collected blood and tissue samples from a recently completed HIVeradication trial!Project NarrativeFor HIVinfected individuals on suppressive antiretroviral therapylatent HIVinfection of resting memory CDT cells is the major barrier to a cureElimination of these latently infected cells by is being pursued as a strategy to cure the infectionThis proposal details the development and optimization of a new molecular assay to measure the number of latently infected cells present in the tissues of HIVinfected individualsfor use in monitoring the efficacy of HIVcure therapies