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Complete title: Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected with HIV-1 Using a Non-Marrow Ablative Conditioning Regimen Containing TBI in Combination with Post-Transplant Immunosuppression with Cyclosporine and Mycophenolate Mofetil
|Research Study Number||1410.00|
|Principal Investigator||Ann Woolfrey, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Patients with hematologic malignancy, lymphoma or other HIV-associated malignancy are eligible provided these criteria are met:
-- * The malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence for continued tumor growth in the case of lymphoma or solid tumors
-- * Highly active antiretroviral therapy (HAART) is initiated within one month of hematopoietic cell transplant
-- * Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy
-- * CD4 count is allowed to be > 100 cells/ul
- HIV infected patients without malignancy who have failed HAART are eligible provided that these criteria are met:
-- * They have been treated with more than one regimen of HAART for a total of at least 6 months duration
-- * The viral load is < 50 copies/ml plasma
-- * The CD4 count < 100 cells/ul
- DONOR: Human leukocyte antigen (HLA) genotypically/phenotypically identical donor; if more than one HLA-identical sibling is available, priority will be given to donors matched for cytomegalovirus (CMV) status, ABO titer, and sex
-- * Peripheral blood stem cells will be collected from donors greater than 12 years of age
-- * Bone marrow will be collected from donors less than 12 years of age
- DONOR: HLA phenotypically identical unrelated donor; match grades allowed:
-- * Match grade 1: Matched at allele level for HLA-A, B, C, DRB1, and DQB1
-- * Match grade 2.1: Single allele disparity for HLA-A, B, C, DRB1, and DQB1
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Patients with other disease or organ dysfunction that would limit survival to less than 30 days
- Patients with medical history of noncompliance with HAART or medical therapy
- DONOR: Donors for whom medical or psychologic reasons would make donor procedure intolerable
- DONOR: Marrow donors who have increased anesthetic risk
- DONOR: Donors who are HIV positive
- DONOR: Age > 75 years
Other exclusion criteria may apply.
Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Immunodeficiency Syndromes; Malignancies in HIV Patients
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