Clinical Trials

MainTitle

Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients (HSCT-HIV)

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2017 by Kirby Institute

Sponsor
Kirby Institute


Information provided by (Responsible Party)
Kirby Institute
ClinicalTrials.gov Identifier
NCT02732457

First received: March 23, 2016
Last updated: August 30, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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
HIV-1 Infection

Study Type: Observational
Study Design: 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
Secondary Outcome Measures:
  • 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

Estimated Enrollment: 10
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)

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.
    1. 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.
    2. 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.
    3. 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.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    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

contacts and locations

Contacts and Locations

Choosing 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

Contacts

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

Locations

Australia
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
More Information

More Information


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  

Keywords provided by Kirby Institute:

HIV
Persistence
Reservoirs
Stem Cell Transplant
Functional Cure

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.