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A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
VIRxSYS Corporation
ClinicalTrials.gov Identifier:
NCT00622232
First received: February 11, 2008
Last updated: June 7, 2011
Last verified: June 2011

February 11, 2008
June 7, 2011
December 2007
January 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the change in log10 HIV-1 RNA level [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622232 on ClinicalTrials.gov Archive Site
Changes in immune function as determined by ICS and TCR vβ Repertoire profile. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
June 2023
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00622232
VRX496-USA-05-002-Rollover
Yes
Tessio Rebello, PhD/Vice President of Clinical Affairs, VIRxSYS Corporation
VIRxSYS Corporation
Not Provided
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
VIRxSYS Corporation
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP