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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Genetic: VRX496-transduced autologous CD4 T cells

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • CIRCLE Medical, LLC
  • New York
    • New York, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	9 months
To evaluate the change in log10 HIV-1 RNA level	9 months
To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in immune function as determined by ICS and TCR vβ Repertoire profile.	9 months

Collaborators and Investigators

• Sponsor: VIRxSYS Corporation
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 11, 2008
• First Submitted That Met QC Criteria: February 21, 2008
• First Posted (Estimate): February 22, 2008

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: HIV-1; treatment experienced, complementary therapies
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: VRX496-USA-05-002-Rollover