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TerminatedNCT02732457HSCT-HIVUpdated Nov 8, 2021

Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients

An observational study in HIV-1 Infection, sponsored by Kirby Institute. Terminated at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.

Sponsored by Kirby Institute · Observational

Why this study was terminated
5 participants recruited in 7 years (no recruitment since 2015). Due to rare patient population and due to ongoing COVID-19 demands on healthcare systems, it was decided by the Protocol Steering Committee to terminate this study.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • HIV-1 Infection

Keywords

  • HIV
  • Persistence
  • Reservoirs
  • Stem Cell Transplant
  • Functional Cure
03

In context

Lead sponsor

Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with HIV infection requiring a HSCT

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR

    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

    Time frame: 3 years

Secondary outcomes

  1. Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot

    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).

    Time frame: 3 years

07

Study locations

1 site
  • St Vincent's Hospital
    Sydney, New South Wales 2010, Australia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02732457
Lead sponsor
Kirby Institute
Responsible party
Sponsor
First posted
Apr 8, 2016
Start date
Sep 2014
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Nov 8, 2021

Study contacts

Mark Polizzotto, MD
principal investigator · St Vincent's Hospital, Sydney

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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