Back to resultsA Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial (Rollover)
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VRX496-transduced autologous CD4 T cells
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, treatment experienced, complementary therapies
Eligibility 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
Sites / Locations
- CIRCLE Medical, LLC
- Jacobi Medical Center
Outcomes
Primary Outcome Measures
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.
To evaluate the change in log10 HIV-1 RNA level
To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion
Secondary Outcome Measures
Changes in immune function as determined by ICS and TCR vβ Repertoire profile.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00622232
Brief Title
A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial
Acronym
Rollover
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
VIRxSYS Corporation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, treatment experienced, complementary therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
VRX496-transduced autologous CD4 T cells
Intervention Description
The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion.
Primary Outcome Measure Information:
Title
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
Title
To evaluate the change in log10 HIV-1 RNA level
Time Frame
9 months
Title
To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Changes in immune function as determined by ICS and TCR vβ Repertoire profile.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tessio E Rebello, PhD
Organizational Affiliation
VIRxSYS Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Stein, M.D.
Organizational Affiliation
Jacobi Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Blick, M.D.
Organizational Affiliation
CIRCLE Medical, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIRCLE Medical, LLC
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Jacobi Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial
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