Clinical Trial

Disease: Human Immunodeficiency Virus Infection, HIV, (NCT04201782)

Disease info:

Human immunodeficiency virus (HIV) is a virus that attacks the immune system by infecting and killing white blood cells known as CD4+ T-cells. CD4+ T-cells represent a vital part of the immune system and untreated HIV infections render patients more vulnerable to dangerous infections by other pathogens, including bacteria and fungi. If the virus remains untreated it can lead to patients developing the life-threatening disease acquired immunodeficiency syndrome (AIDS). Untreated HIV can leave people vulnerable to life-threatening infections. HIV symptoms often manifest as flu-like symptoms such as fever, chills, rash, night sweats, muscle aches, sore throat, and fatigue. Today, antiviral medications can allow people living with HIV to live healthy lives.


In 2021, 36,136 people received an HIV diagnosis in the United States and dependent areas. An estimated 1.2 million people in the United States had HIV at the end of 2021.
Official title:
Long-Term Follow-up of HIV-Infected Subjects Treated With Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases (SB-728-T or SB-728mR-T)

United States, California 
Quest Clinical Research, San Francisco, California, United States, 94115

United States, Connecticut 
Circle CARE Center, LLC, Norwalk, Connecticut, United States, 06850

United States, Florida 
Orlando Immunology Center, Orlando, Florida, United States, 32803

United States, Texas 
Central Texas Clinical Research, Austin, Texas, United States, 78705

Study start:
Mar. 18, 2011
38 participants
Gene editing method:
Zinc Finger Nucleases (ZFN)
Type of edit:
Gene knock-out
C-C chemokine receptor type 5 (CCR5)
Delivery method:
Adenoviral - Ex-vivo
Study terminated in January 2024: There have been no significant safety issues in any subjects exposed between 7.5 and 13.5 years ago to either SB-728-T or SB-728mR-T, including no delayed adverse events related to the investigational product.
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Terminated


Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T. Enrolling subjects will be followed for a total of 12 years.
Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T will be eligible to participate in this trial. There will be no treatment in this long-term follow-up study. Subjects who choose to enroll into this extension study will be evaluated for a total of 12 years.

Last updated: Jan. 28, 2024
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