Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV-1 Infection

Keywords

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HIV Persistence Reservoirs Stem Cell Transplant Functional Cure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Polizzotto, MD

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital, Sydney

Locations

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St Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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IVPPHSCT01

Identifier Type: -

Identifier Source: org_study_id