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Gene transfer with chemotherapy for recently HIV-1 diagnosed adults taking antiretroviral drugs

2 years ago Doherty Institute Community
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Study type
Summary
Inclusion Criteria
Participation requirements
Status
Interventional, proof-of-concept The gene transfer study involves the administration of an inactive virus Cal-1 (LVsh5/C46) after chemotherapy. Cal-1 has two functions – the first to remove the HIV co-receptor CCR5 and the second to block HIV infection. Participants will be monitored after chemotherapy and gene transfer for over 6 months and then taken off ART to see if the modified cells can control infection.
  • HIV+
  • Diagnosis and treatment start early after infection
  • CD4+ ≥ 500 cells/μL
  • plasma RNA < 50 copies/mL
  • Eligible participants will undergo screening to confirm eligibility. White blood cells will then be collected by leukapheresis (a procedure which takes 3-4 hours) following 5 days of administration of bone-marrow mobilising medications. Antiretroviral treatment will be stopped for 4 weeks during the mobilisation and collection phase.  The collected cells will be modified by gene transfer in the laboratory. 1-2 days of chemotherapy will be administered before re-infusion of the gene transfer modified cells. Participants will then be monitored for 26 weeks (6 months), and antiretroviral treatment stopped again if deemed safe. Further monitoring will be conducted for up to another 48 weeks (1 year), and treatment recommenced if necessary. Currently recruiting

    Study contact
    Ms Karen MacRae at St Vincent’s Hospital, Darlinghurst on +61 2 8382 2670, or by email at Karen.MacRae@svha.org.au

    Click here for more details

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    Doherty Institute

    Doherty Institute

    Finding solutions to prevent, treat and cure infectious diseases and understanding the complexities of microbes and the immune system requires innovative approaches and concentrated effort. This is why The University of Melbourne – a world leader in education, teaching and research excellence – and The Royal Melbourne Hospital – an internationally renowned institution providing outstanding care, research and learning – have partnered to create the Peter Doherty Institute for Infection and Immunity (Doherty Institute); a centre of excellence where leading scientists and clinicians collaborate to improve human health globally.

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    Supported by the National Institute Of Allergy And Infectious Diseases of the National Institutes of Health under Award Number U19AI096109. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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