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

Sponsored by:	VIRxSYS Corporation
Information provided by:	VIRxSYS Corporation
ClinicalTrials.gov Identifier:	NCT00622232

Purpose

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	Intervention	Phase
HIV Infections	Genetic: VRX496-transduced autologous CD4 T cells	Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by VIRxSYS Corporation:

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. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
To evaluate the change in log10 HIV-1 RNA level [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in immune function as determined by ICS and TCR vβ Repertoire profile. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622232

Locations

United States, Connecticut
CIRCLE Medical, LLC
Norwalk, Connecticut, United States, 06851
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
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:	Richard Greenberg, M.D.	University of Kentucky
Principal Investigator:	Gary Blick, M.D.	CIRCLE Medical, LLC

More Information

Responsible Party:	VIRxSYS Corporation ( Tessio Rebello, PhD/Vice President of Clinical Affairs )
Study ID Numbers:	VRX496-USA-05-002-Rollover
Study First Received:	February 11, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00622232
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIRxSYS Corporation:

HIV-1
treatment experienced, complementary therapies

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009