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

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.

Study Overview

• Status: Terminated
• Conditions: 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
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • St Vincent's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with HIV infection requiring a HSCT

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 years

Collaborators and Investigators

• Sponsor: Kirby Institute
• Investigators: Principal Investigator: Mark Polizzotto, MD, St Vincent's Hospital, Sydney

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 31, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Stem Cell Transplant; Persistence; Functional Cure; Reservoirs
• Other Study ID Numbers: IVPPHSCT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED