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An Adaptive Phase I/II Study of the Safety of CD4+ T Lymphocytes and CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct, With and Without Conditioning With Busulfan in HIV-1 Infected Adults Previously Exposed to ART

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Trial Profile

An Adaptive Phase I/II Study of the Safety of CD4+ T Lymphocytes and CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct, With and Without Conditioning With Busulfan in HIV-1 Infected Adults Previously Exposed to ART

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Busulfan (Primary) ; Cal 1 (Primary) ; Cal-1 transduced T cells (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacogenomic; Pharmacokinetics
  • Sponsors Calimmune

    • Most Recent Events

    • 17 Mar 2021 Patients from this study was used to characterized the neutrophil dynamics after busulfan administration in HIV+ patients using population pharmacokinetic/pharmacodynamic (PK/PD) modeling, presented at the 122nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 06 Feb 2018 Status changed from active, no longer recruiting to completed.
    • 28 Nov 2016 Planned End Date changed from 1 Sep 2017 to 1 Oct 2017.

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