Status:
UNKNOWN
A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial
Lead Sponsor:
VIRxSYS Corporation
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 therape...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00622232
Start Date
December 1 2007
End Date
June 1 2023
Last Update
June 8 2011
Active Locations (2)
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1
CIRCLE Medical, LLC
Norwalk, Connecticut, United States, 06851
2
Jacobi Medical Center
New York, New York, United States, 10461