Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients (HSCT-HIV)
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|ClinicalTrials.gov Identifier: NCT02732457|
Recruitment Status : Recruiting
First Posted : April 8, 2016
Last Update Posted : February 18, 2021
|Condition or disease|
- 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.
- 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.
- 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.
- 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 Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients|
|Actual Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2024|
- Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR [ Time Frame: 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
- Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot [ Time Frame: 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).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732457
|Contact: Mark Polizzotto, MDfirstname.lastname@example.org|
|Australia, New South Wales|
|St Vincent's Hospital||Recruiting|
|Sydney, New South Wales, Australia, 2010|
|Contact: Mark Polizzotto, MD 612 93555658 email@example.com|
|Principal Investigator:||Mark Polizzotto, MD||St Vincent's Hospital, Sydney|