Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects
Completed · Phase 1/Phase 2
Conditions studied: HIV, HIV Infection
In brief
This research study is being carried out to study a new way to possibly treat human immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases. The CCR5 gene is required for certain types of HIV to enter into and infect 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 the CCR5 gene on their T-Cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 genes on their T-cells and their HIV disease is less severe and is slower to cause disease (AIDS). The purpose of this research study is to find out whether SB-728-T is safe to give to humans and find out how this affects HIV.
Key facts
- Study ID
- NCT01252641
- Run by
- Sangamo Therapeutics
- People needed
- 21
- Starts
- 2010-11-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2019-09-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented HIV infection
- CD4+ T-cell count >500 cell per millimeter cubed (cells/mm3)
- CD4+ T-cell nadir of >400 cells/mm3
- HIV viral load >1,000 copies per milliliter (mL)
You may not qualify if…
- Any viral hepatitis
- Acute HIV infection
- HIV viral load >1,000,000 copies/mL
- Active or recent (prior 6 months) AIDS defining complication
- Any HIV medications within the past 12 weeks
- Cancer or malignancy that has not been in remission for at least 5 years with the exception of successfully treated basal cell carcinoma of the skin
- Current diagnosis of NYHA grade 3 or 4 congestive heart failure or uncontrolled angina or arrhythmias
- History of bleeding problems
- Use of chronic steroids in past 30 days
- Pregnant or breast feeding
- Active drug or alcohol abuse
- Serious illness in past 30 days
- Currently participating in another clinical trail or any prior gene therapy
Where it is running
- UCLA CARE Center — Los Angeles, California, United States
- Orange Coast Medical Group — Newport Beach, California, United States
- Quest Clinical Research — San Francisco, California, United States
- Orlando Immunology Center — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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