HSCT-HIV: Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune response.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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To assess the impact of HSCT on the immune response to HIV by measuring HIV specific antigens in peripheral blood (via immune assays such as ELISA and Western blot) longitudinally.
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To measure the decay of persisting HIV by sequencing and quantitating HIV RNA in plasma, and HIV DNA and RNA in peripheral blood cells including CD4+ T cells and CD4+ T cell subsets, as well as in tissue cells derived from fine needle lymph node aspirates, and/or bone marrow aspirates, and/or rectal tissue.
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To determine the presence of the CCR5 delta 32 allele in the patient prior to and following HSCT which will provide information regarding the presence of this gene in the donor cells.
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To correlate these findings to the clinical outcome of the individuals enrolled in this study based on their clinical standard of care assessments following HSCT.
Study Design
Outcome Measures
Primary Outcome Measures
- Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR [3 years]
HIV-1 DNA in CD4+ T cells will be measured by real-time PCR and reported as HIV-1 DNA copies in 10e6 CD4+ T cells
Secondary Outcome Measures
- Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot [3 years]
HIV-1 antigens and antibodies (Ag/Ab) in peripheral blood will be measured by 4th generation chemiluminescence microparticle immunoassay (CMIA) and by Western blot (WB).
Eligibility Criteria
Criteria
Inclusion Criteria:
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HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist).
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Over 18 years of age
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Provision of written, informed consent
Exclusion Criteria:
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In the opinion of the investigator that the patient is not able to provide informed consent
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Hb < 9 (g/dL)
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CD4+ T cell count <100 (cells/µl)
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Serious coagulation abnormalities, platelet count < 50.
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Patients currently taking medications that significantly affect the bleeding time (e.g. warfarine, clexane, FXa antagonists)
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History of allergy to local anaesthetics
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Vincent's Hospital | Sydney | New South Wales | Australia | 2010 |
Sponsors and Collaborators
- Kirby Institute
Investigators
- Principal Investigator: Mark Polizzotto, MD, St Vincent's Hospital, Sydney
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IVPPHSCT01