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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
Information provided by:
VIRxSYS Corporation

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.

Condition or disease Intervention/treatment Phase
HIV Infections Genetic: VRX496-transduced autologous CD4 T cells Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
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
Study Start Date : December 2007
Actual Primary Completion Date : January 2009
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]
  2. To evaluate the change in log10 HIV-1 RNA level [ Time Frame: 9 months ]
  3. To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Changes in immune function as determined by ICS and TCR vβ Repertoire profile. [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

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United States, Connecticut
Norwalk, Connecticut, United States, 06851
United States, New York
Jacobi Medical Center
New York, New York, United States, 10461
Sponsors and Collaborators
VIRxSYS Corporation
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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
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Responsible Party: Tessio Rebello, PhD/Vice President of Clinical Affairs, VIRxSYS Corporation
ClinicalTrials.gov Identifier: NCT00622232    
Other Study ID Numbers: VRX496-USA-05-002-Rollover
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Keywords provided by VIRxSYS Corporation:
treatment experienced, complementary therapies
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases