A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial (Rollover)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00622232|
Recruitment Status : Active, not recruiting
First Posted : February 22, 2008
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Genetic: VRX496-transduced autologous CD4 T cells||Phase 2|
The study has concluded it's 9-month active phase. Subjects are currently in a 15-year Long Term Follow-up Phase of the study.
In keeping with the recently released Guidance on Monitoring For Delayed Adverse Events, that states that for the first 5 years all subjects should undergo monitoring of vector sequences every 6 months, subjects will visit the clinic at a maximum of 6 months intervals for a blood test evaluating persistence of vector sequences.
Therefore for the first 5 years, subjects will have 6 months visits for safety assessment. For years 6 to 15, subjects will be contacted by phone or mail. At these contacts, subjects will be asked about their health status.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||January 2009|
|Estimated Study Completion Date :||June 2023|
- Genetic: VRX496-transduced autologous CD4 T cells
The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion.
- 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. [ Time Frame: 9 months ]
- To evaluate the change in log10 HIV-1 RNA level [ Time Frame: 9 months ]
- To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion [ Time Frame: 9 months ]
- Changes in immune function as determined by ICS and TCR vβ Repertoire profile. [ Time Frame: 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622232
|United States, Connecticut|
|CIRCLE Medical, LLC|
|Norwalk, Connecticut, United States, 06851|
|United States, New York|
|Jacobi Medical Center|
|New York, New York, United States, 10461|
|Study Director:||Tessio E Rebello, PhD||VIRxSYS Corporation|
|Principal Investigator:||David Stein, M.D.||Jacobi Medical Center|
|Principal Investigator:||Gary Blick, M.D.||CIRCLE Medical, LLC|