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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
Sponsor:
Information provided by:
VIRxSYS Corporation

Tracking Information
First Submitted Date  ICMJE February 11, 2008
First Posted Date  ICMJE February 22, 2008
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE December 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2008)		 Changes in immune function as determined by ICS and TCR vβ Repertoire profile. [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2008)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00622232
Other Study ID Numbers  ICMJE VRX496-USA-05-002-Rollover
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Tessio Rebello, PhD/Vice President of Clinical Affairs, VIRxSYS Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE VIRxSYS Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account VIRxSYS Corporation
Verification Date June 2011

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