CCR5-modified CD4+ T Cells for HIV Infection — TRAILBLAZER  

HIV Infections Clinical Trial

Official title: T-Cell Reinfusion After Interfering With Lymphocyte Binding Location of AIDS Virus Through Zinc-finger-nuclease Elimination of CCR5 Receptors: The TRAILBLAZER Study

Status Active, not recruiting

Clinical Trial Summary

A Comparative Study of Autologous CD4+ T Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 versus ex vivo Expanded Unmodified Autologous CD4+ T Cells in Treated HIV-1 Infected Subjects

Clinical Trial Description

This is a randomized clinical trial comparing the effect of infusing expanded autologous CD4+ T cells with or without ex vivo modification of the CCR5 gene by zinc finger nucleases among HIV-infected patients with plasma HIV RNA levels <50 copies/mL for at least 48 weeks and CD4+ T cell counts greater than 350 cells/µL. The main hypothesis is that the infusion of modified CD4+ T cells will lead to a reduction in the size of the replication-competent HIV reservoir, that is greater than that resulting from infusion of unmodified CD4+ T cells. A total of 30 participants will be randomized to receive one infusion of 0.5 - 4 x 1010 ex vivo expanded autologous CD4+ T cells that have been either modified by transduction with a zinc finger nuclease designed to cleave CCR5 (arm 1, n=20) or unmodified (arm 2, n=10). All participants will be pre-treated with cyclophosphamide at a dose of 1 g/m2 before infusion. The primary outcome measure the difference in the magnitude of change in intact provirus from before infusion to 96 weeks after infusion between the two study arms. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

• NCT number: NCT03666871
• Study type: Interventional
• Source: University of Cincinnati
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 12, 2019
• Completion date: February 28, 2024