Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Kirby Institute
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT02732457
First received: March 23, 2016
Last updated: April 7, 2016
Last verified: April 2016
  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

Resource links provided by NLM:


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.
  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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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: Kersten K Koelsch, MD +61-2-9385-0466 kkoelsch@kirby.unsw.edu.au

Locations
Australia, New South Wales
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Kersten K Koelsch, MD    +61283821111    kkoelsch@kirby.unsw.edu.au   
Sponsors and Collaborators
Kirby Institute
Investigators
Study Director: Kersten K Koelsch, MD The Kirby Institute, UNSW Medicine, UNSW Australia
  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: April 7, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on May 25, 2017