期刊
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA
卷 103, 期 46, 页码 17372-17377出版社
NATL ACAD SCIENCES
DOI: 10.1073/pnas.0608138103
关键词
clinical trials; HIV; immunotherapy; gene therapy
资金
- NIAID NIH HHS [2R44AI051908, U19 AI066290-010001, R44 AI051908, U19 AI066290, U19-AI066290] Funding Source: Medline
We report findings from a clinical evaluation of lentiviral vectors in a phase I open-label nonrandomized clinical trial for HIM This trial evaluated the safety of a conditionally replicating HIV-1-derived vector expressing an antisense gene against the HIV envelope. Five subjects with chronic HIV infection who had failed to respond to at least two antiviral regimens were enrolled. A single i.v. infusion of gene-modified autologous CD4 T cells was well tolerated in all patients. Viral loads were stable, and one subject exhibited a sustained decrease in viral load. CD4 counts remained steady or increased in four subjects, and sustained gene transfer was observed. Self-limiting mobilization of the vector was observed in four of five patients. There is no evidence for insertional mutagenesis after 21-36 months of observation. immune function improved in four subjects. Lentiviral vectors appear promising for gene transfer to humans.
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