Human Immunodeficiency Virus Clinical Trial
Official title:
Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients
Combined antiretroviral therapy (cART) efficiently suppress viral replication in majority of AIDS patients. The morbidity and mortality of the disease has dramatically decreased over the past 20 years. However, chronic human immunodeficiency virus-1 (HIV-1) infection lead to profound immune defects in some advanced AIDS patients who often develop with severe opportunistic infections (OIs), severe cachexia and other deadly complications, which accounts for the major death group even under cART. Up-to-date, there are no effective immune interventions to restore host holistic immunity for advanced AIDS patients.
Advanced AIDS patients are usually characterized with CD4 T cells less than 200 cells/uL,
including end-stage AIDS patients (CD4 T cells less than 50 cells/uL), and often accompanied
with severe opportunistic infections (including tuberculosis, PCP, fungus and so on) and
deadly complications.In this regard, advanced AIDS patients present a unique and special
profound immune deficiency setting. Therefore, increasing attention and evidence have been
paid to development of novel immune therapeutic strategies for those patients.
Immune cell therapy in combination with anti-infection and anti-HIV therapy may open a new
direction for advanced AIDS patients, but single cell-based immune therapies do not work well
for advanced AIDS patients. Over past 30 years, more than hundreds of AIDS patients with
haematological malignancies received autologous or allogeneic hematopoietic stem cell
transfusion (HSCT), and their survival rate had been improved to the levels equal to non-HIV
patients; however, allogeneic HSCT is only limited to treat AIDS patients with lymphoma or
leukemia. The only cured Berlin Patient, who suffered from both acute myeloid leukemia and
chronic HIV-1 infection, was transplanted with homozygous CCR5 delta 32 allogeneic
HLA-matched stem cells and acquired a long-term remission of both leukemia and AIDS. However,
it is very difficult to find the HLA-identical HSCT with CCR5 delta 32 homogenous donors for
AIDS patients in clinic. Granulocyte colony-stimulating factor (G-CSF)-mobilized donor
peripheral blood mononuclear cells (MNCs) are a heterogeneous population of immune cells that
have a potential role in immunomodulation and hemopoiesis. Here, we hypothesized that
HLA-mismatched MNCs transfusion can be used to comprehensively restore or boost the host
holistic immune system for advanced AIDS patients, to the degree similar as the allogeneic
HSCT for leukemia patients.
The purpose of this study is to investigate the safety and initial efficacy of allogeneic
adoptive immune therapy (AAIT) for advanced AIDS patients. 20 patients received i.v.
transfusion one round (3 times) of 2.0-3.0*10E8 cells/kg of MNSs as the treated group. All of
them received the conventional (anti-opportunistic infection and ART) treatment for AIDS. The
side effects, symptom improvement, control of opportunistic infections and CD4 T cell numbers
will be evaluated during the 48-week follow up.
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