Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients (HSCT-HIV)
Verified August 2017 by Kirby Institute
Information provided by (Responsible Party)
First received: March 23, 2016
Last updated: August 30, 2017
Last Verified: August 2017
History of Changes
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.
Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients|
Further study details as provided by Kirby Institute:
Primary Outcome Measures
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
PBMC, BMMC, lymph-node derived cells
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||September 2019|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
- 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)
- 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
Ages Eligible for Study: 18 Years and older Sexes Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Probability Sample
Study PopulationPatients with HIV infection requiring a HSCT
- HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist).
- Over 18 years of age
- Provision of written, informed consent
- In the opinion of the investigator that the patient is not able to provide informed consent
- Hb < 9 (g/dL)
- CD4+ T cell count <100 (cells/µl)
- Serious coagulation abnormalities, platelet count < 50.
- Patients currently taking medications that significantly affect the bleeding time (e.g. warfarine, clexane, FXa antagonists)
- History of allergy to local anaesthetics
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02732457
|Contact: Mark Polizzotto, MDemail@example.com|
Locations Show More
|St Vincent's Hospital||Recruiting|
|Sydney, New South Wales, Australia, 2010|
Contact: Mark Polizzotto, MD  612 93555658  firstname.lastname@example.org
Sponsors and CollaboratorsKirby Institute
|Principal Investigator:||Mark Polizzotto, MD||St Vincent's Hospital, Sydney|
|Responsible Party:||Kirby Institute|
|ClinicalTrials.gov Identifier:||NCT02732457 History of Changes|
|Other Study ID Numbers:||IVPPHSCT01|
|Study First Received:||March 23, 2016|
|Last Updated:||August 30, 2017|
|Individual Participant Data|
|Plan to Share IPD:||Undecided|
Keywords provided by Kirby Institute:HIV
Stem Cell Transplant
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.