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