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

NCT00622232 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-06-08

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

GENETIC

VRX496-transduced autologous CD4 T cells

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

Sponsors & Collaborators

  • VIRxSYS Corporation

    lead INDUSTRY

Principal Investigators

  • Tessio E Rebello, PhD · VIRxSYS Corporation

  • David Stein, M.D. · Jacobi Medical Center

  • Gary Blick, M.D. · CIRCLE Medical, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-01-31
Completion
2023-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622232 on ClinicalTrials.gov