Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients

Terminated

• Conditions: HIV-1 Infection

• Registration Number: NCT02732457
• Lead Sponsor: Kirby Institute

Brief 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.

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-31
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot	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).

Trial Locations

Locations (1)

St Vincent's Hospital; 🇦🇺 Sydney, New South Wales, Australia