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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 : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

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
HIV-1 Infection

Detailed Description:
  1. 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.
  2. 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.
  3. 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.
  4. 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
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with HIV infection requiring a HSCT
Criteria

Inclusion Criteria:

  • HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist).
  • Over 18 years of age
  • Provision of written, informed consent

Exclusion Criteria:

  • 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
  • Pregnancy

Information from the National Library of Medicine

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


Contacts
Contact: Mark Polizzotto, MD 293850900 mpolizzotto@kirby.unsw.edu.au

Locations
Australia, New South Wales
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Mark Polizzotto, MD    612 93555658    mpolizzotto@kirby.unsw.edu.au   
Sponsors and Collaborators
Kirby Institute
Investigators
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
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kirby Institute:
HIV
Persistence
Reservoirs
Stem Cell Transplant
Functional Cure