Rollover
A Rollover Study to Evaluate Safety and Therapeutic Effect of Re-infusing Subjects Who Completed Participation in the VRX496-USA-05-002 Trial With Autologous T Cells Transduced With VRX496
Sponsor study identifier
interventional
40
1 country
2
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating additional therapeutic benefits with respect to viral load and CD4 counts.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
February 11, 2008
Actual (reported)February 22, 2008
Actual (reported)January 2009
Actual (reported)June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To evaluate the safety and tolerability of an additional infusion of VRX496 CD4+ T cells in subjects who previously received VRX496 CD4 T cells under protocol VRX496-USA-05-002.
9 months
To evaluate the change in log10 HIV-1 RNA level
9 months
To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion
9 months
Changes in immune function as determined by ICS and TCR vβ Repertoire profile.
9 months
The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CIRCLE Medical, LLC
Norwalk, Connecticut, 06851, United States
Jacobi Medical Center
New York, New York, 10461, United States
Tessio E Rebello, PhD
VIRxSYS Corporation
David Stein, M.D.
Jacobi Medical Center
Gary Blick, M.D.
CIRCLE Medical, LLC
First Submitted
February 11, 2008
First Posted
February 22, 2008
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients
Contact the study team to confirm eligibility.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 8, 2011
Record last verified: 2011-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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