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

Kirby Institute

Status: Terminated

Conditions: HIV-1 Infection

Study type: Observational

Funder types: Other

Identifiers

NCT02732457

IVPPHSCT01

Details and patient eligibility

About

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.

Full description

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. 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. 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. 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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