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Gene transfer in humans using a conditionally replicating lentiviral vector.

Bruce L Levine1, Laurent M Humeau, Jean Boyer

  • 1Abramson Family Cancer Research Institute, University of Pennsylvania Cancer Center, Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.

Proceedings of the National Academy of Sciences of the United States of America
|November 9, 2006
PubMed
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This summary is machine-generated.

This clinical trial shows lentiviral vectors are safe for gene therapy in HIV patients. Gene-modified cells were well-tolerated, with some patients showing improved immune function and viral load.

Area of Science:

  • Virology
  • Immunology
  • Gene Therapy

Background:

  • Human Immunodeficiency Virus (HIV) infection remains a significant global health challenge.
  • Current antiviral regimens have limitations, necessitating novel therapeutic strategies.
  • Lentiviral vectors offer a potential platform for gene-based interventions against HIV.

Purpose of the Study:

  • To evaluate the safety and tolerability of a lentiviral vector-based gene therapy in patients with chronic HIV infection.
  • To assess the efficacy of gene-modified autologous CD4 T cells in managing HIV viral load and immune status.
  • To investigate the long-term effects of lentiviral vector gene transfer, including insertional mutagenesis and immune function.

Main Methods:

  • A phase I, open-label, nonrandomized clinical trial was conducted.

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  • Five subjects with chronic HIV infection, refractory to multiple antiviral regimens, were enrolled.
  • A single intravenous infusion of autologous CD4 T cells, genetically modified with a lentiviral vector expressing an antisense gene against the HIV envelope, was administered.

    • Main Results:

    • The gene therapy was well-tolerated by all participants.
    • Viral loads remained stable in most subjects, with one experiencing a sustained decrease.
    • CD4 T cell counts stabilized or increased in four subjects, indicating potential immune reconstitution.
    • Sustained gene transfer was confirmed, and no evidence of insertional mutagenesis was observed up to 36 months post-infusion.
    • Immune function showed improvement in four out of five subjects.

    Conclusions:

    • Lentiviral vectors demonstrate a promising safety profile for human gene transfer applications.
    • This gene therapy approach holds potential for managing HIV infection and improving immune function.
    • Further research is warranted to explore the full therapeutic potential of lentiviral vectors in HIV treatment.