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

• ClinicalTrials.gov Identifier: NCT00622232
• Recruitment Status: Active, not recruiting
• First Posted: February 22, 2008
• Last Update Posted: June 8, 2011
• Sponsor: VIRxSYS Corporation
• Information provided by: VIRxSYS Corporation

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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 Collaborators

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

More Information

• 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
• Last Update Posted: June 8, 2011
• Last Verified: June 2011

Keywords provided by VIRxSYS Corporation:

HIV-1; treatment experienced, complementary therapies

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases