Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02732457

Acronym

HSCT-HIV

Enrollment

Registered

2016-04-08

Start date

2014-09-30

Completion date

2015-02-28

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection

Keywords

HIV, Persistence, Reservoirs, Stem Cell Transplant, Functional Cure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Australia

Outcome results