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

Status unconfirmed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00622232

Run by

VIRxSYS Corporation

People needed

40

Starts

2007-12-01

Expected to finish

2023-06-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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