Status:
COMPLETED
Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects
Lead Sponsor:
Sangamo Therapeutics
Conditions:
HIV
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 a...
Detailed Description
Laboratory studies have shown that when CD4+ T-cells are modified with Zinc Finger Nucleases SB-728, HIV is prevented from killing the CD4+ T-cells. On the basis of these laboratory results, there is ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01252641
Start Date
November 1 2010
End Date
May 1 2015
Last Update
September 20 2019
Active Locations (4)
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1
UCLA CARE Center
Los Angeles, California, United States, 90035
2
Orange Coast Medical Group
Newport Beach, California, United States, 92663
3
Quest Clinical Research
San Francisco, California, United States, 94115
4
Orlando Immunology Center
Orlando, Florida, United States, 32803