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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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