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.
Study Director: Winson Tang, M.D. Sangamo Therapeutics Inc.
United States, California
UCLA Center for AIDS Research and Education, Los Angeles, California, United States, 90035
Orange Coast Medical Group, Newport Beach, California, United States, 92663
Quest Clinical Research, San Francisco, California, United States, 94115
United States, Connecticut
Circle CARE Center, LLC, Norwalk, Connecticut, United States, 06851
United States, Florida
Orlando Immunology Center, Orlando, Florida, United States, 32803
United States, Missouri
Central West Clinical Research, Inc., St Louis, Missouri, United States, 63108
United States, New Mexico
Southwest CARE Center, Santa Fe, New Mexico, United States, 87505
United States, New York
Ricky K Hsu, MD, PC, New York, New York, United States, 10011
United States, Texas
Gordon Crofoot, MD, PA, Houston, Texas, United States, 77098
Status: Completed
Description
This research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain types of HIV (CCR5 tropic) to enter into and infect your T-cells. T cells are one of the white blood cells used by the body to fight HIV. The most important of these are called "CD4 T-cells."
Some People are born without CCR5 on their T-cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and their HIV disease is less severe and is slower to cause disease (AIDS).
Even with no detectable levels of HIV in the blood, HIV remains in some tissues in the body, primarily the gut tissue. HIV infects the CD4+ T-cells including in the blood and gut. The new treatment to be studied will involve removing white blood cell from the blood that contains CD4+ T-cells. The extracted CD4+ T-cells are then genetically modified by the ZFNs to be resistant to infection by HIV by removing the CCR5 gene from the surface of the CD4+ T cell where HIV enters the cell. Additional genetically modified cells are manufactured and then re-infused back into you. Researchers hope that these genetically modified cells will be resistant to infection by HIV and will be able to reproduce additional resistant CD4+ T-cells in your body.
Laboratory studies have shown that when CD4+ T-cells are modified with ZFNs, HIV is prevented from killing the CD4+ T-cells. On the basis of these laboratory results, thre is the potential that ZFNs may work in humans infected with HIV and improve their immune system by allowing their CD4+ T-cells to survive longer.
The purpose of this research study is to find out whether "zinc finger" modified CD4+ T-cells are safe to give to humans and find how "zinc finger" modified T-cell affects HIV.
Last updated: Jun. 13, 2023