A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial (Rollover)
Information provided by (Responsible Party)
First received: February 11, 2008
Last updated: June 7, 2011
Last Verified: June 2011
History of Changes
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.
Genetic : VRX496-transduced autologous CD4 T cells
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
Further study details as provided by VIRxSYS Corporation:
Primary Outcome Measures
- 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 ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||June 2023|
|Estimated Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
- Subjects who have successfully completed participation in the VRX496-USA-05-002 trial.
- Subjects who initiated or changed to a new ARV regimen more than 3 months prior to Entry Assessment are eligible.
- Subjects that who (1) if on ARVs and are willing to continue on the current therapy unchanged, or (2) if not on ARV willing to remain off ARVs for the duration of the trial i.e. 9 months. However, if there is clinical need to start or change ARV therapy, then it is permitted to do so.
- CD4 counts decreased by ≥25% from baseline in main study.
- Viral load increased by ≥ 1.0 log from baseline in main study or ≥ 200,000.
- Female subjects who are of reproductive potential who have a positive serum B HCG at the Entry Assessment visit or are not willing to use a reliable method of barrier contraception.
- Are breast-feeding.
- Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use).
- Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol
- Active HIV-related or non HIV-related illness
- Subjects who do not have additional cell product available
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622232
Locations Show More
|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|
Sponsors and CollaboratorsVIRxSYS Corporation
|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|
|Responsible Party:||Tessio Rebello, PhD/Vice President of Clinical Affairs, VIRxSYS Corporation|
|ClinicalTrials.gov Identifier:||NCT00622232 History of Changes|
|Other Study ID Numbers:||VRX496-USA-05-002-Rollover|
|Study First Received:||February 11, 2008|
|Last Updated:||June 7, 2011|
Keywords provided by VIRxSYS Corporation:HIV-1
treatment experienced, complementary therapies
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on August 03, 2020
This information is provided by ClinicalTrials.gov.