HIV stands for human immunodeficiency virus. It harms the immune system by destroying the white blood cells that fight infection. This puts at risk for serious infections and certain cancers.
AIDS stands for acquired immunodeficiency syndrome. It is the final stage of infection with HIV. Not everyone with HIV develops AIDS.
Principal Investigator: Amrita Y. Krishnan, MD City of Hope Medical Center
United States, California
City of Hope Medical Center, Duarte, California, United States, 91010
UCLA CARE Center, Los Angeles, California, United States, 90035
Mills Clinical Research, Los Angeles, California, United States, 90069
Quest Clinical Research, San Francisco, California, United States, 94115
United States, Connecticut
Circle CARE Center, LLC, Norwalk, Connecticut, United States, 06850
Status: Active not recruiting
Description
The purpose of the study is to evaluate the safety and feasibility of administering SB-728mR-HSPC after conditioning with busulfan.
The objective of the study is to evaluate the safety and feasibility of giving autologous SB-728mR-HSPC to HIV-1 (R5) infected patients who are being treated with cART and have undetectable virus but suboptimal CD4+ cell levels. To strengthen the possibility that CCR5-disrupted HSPCs engraft, patients will receive either a two- or three-day (Cohort 1 or Cohort 2) course of busulfan (dose targeting AUC of 4000 µM/day) before being infused with the genetically modified cells. At 9-12 months after SB-728mR-HSPC infusion, subjects who are aviremic with CD4 cell counts ≥600 cells/µL and have ≥1% CCR5-modified CD4 cells within the peripheral blood detected by pentamer PCR will undergo an ATI.
Last updated: Jun. 13, 2023