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

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 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 Study Completion Date:	June 2023
Primary Completion Date:	January 2009 (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.

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.

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, 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

No publications provided

Responsible Party:	Tessio Rebello, PhD/Vice President of Clinical Affairs, VIRxSYS Corporation
ClinicalTrials.gov Identifier:	NCT00622232 History of Changes
Other Study ID Numbers:	VRX496-USA-05-002-Rollover
Study First Received:	February 11, 2008
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIRxSYS Corporation:

HIV-1
treatment experienced, complementary therapies

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 22, 2013