Anti-human immunodeficiency virus hematopoietic progenitor cell-delivered ribozyme in a phase I study: myeloid and lymphoid reconstitution in human immunodeficiency virus type-1-infected patients

Hum Gene Ther. 2004 Mar;15(3):251-62. doi: 10.1089/104303404322886101.

Abstract

A phase I gene transfer clinical study was undertaken to examine the ability to introduce a potential anti-human immunodeficiency virus (HIV) gene therapeutic into hematopoietic progenitor cells (HPC), thereby contributing to multilineage engraftment. The potential therapeutic effect of genetically modifying HPC with protective genes in HIV-infected adults depends in part on the presence of adult thymic activity and myeloid capacity in the setting of HIV replication. Herein we report the presence and expression of a retroviral vector encoding an anti-HIV-1 ribozyme in mature hematopoietic cells of different lineages, and de novo T-lymphocyte development ensuing from genetically engineered CD34(+) HPC. Sustained output of vector-containing mature myeloid and T-lymphoid cells was detected even in patients with multidrug-resistant infection. In addition, the study showed that the degree of persistence of gene-containing cells was dependent on transduced HPC dose. These novel findings support the concept of gene therapy as a modality to effect immune reconstitution with cells engineered to inhibit HIV replication and this report represents the first demonstration of long-term maintenance of a potential therapeutic transgene in HIV disease.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Anti-HIV Agents*
  • Antigens, CD34 / analysis
  • CD4-Positive T-Lymphocytes / metabolism
  • Female
  • Gene Expression
  • Gene Transfer Techniques
  • Genetic Therapy / methods*
  • Genetic Vectors
  • HIV Infections / immunology*
  • HIV Infections / therapy
  • HIV-1* / genetics
  • Hematopoietic Stem Cell Transplantation*
  • Hematopoietic Stem Cells / cytology
  • Hematopoietic Stem Cells / enzymology
  • Humans
  • Lymphocytes / cytology
  • Lymphocytes / metabolism
  • Male
  • Middle Aged
  • Myeloid Cells / cytology
  • Polymerase Chain Reaction
  • RNA, Catalytic / genetics*
  • Retroviridae / genetics

Substances

  • Anti-HIV Agents
  • Antigens, CD34
  • RNA, Catalytic