Last updated on May 2009

Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1

Brief description of study

OBJECTIVES: I. Determine the safety of total body irradiation and post-transplant cyclosporine and mycophenolate mofetil in high-risk patients with human immunodeficiency virus-1. II. Determine whether this regimen results in stable mixed donor lymphocyte chimerism (5-95% donor CD3) in this patient population. III. Determine the kinetics of immune reconstruction following this treatment regimen in this patient population. IV. Determine the effect of this treatment regimen on viral load in this patient population.

Detailed Study Description

PROTOCOL OUTLINE: Patients receive oral or IV cyclosporine 2-3 times daily on Days -1 to 50. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation on Day 0 (assuming donor is available). Beginning within 6 hours of transplantation, patients receive oral mycophenolate mofetil every 12 hours until Day 27. Patients with an unstable level of chimerism may receive 1-2 donor lymphocyte infusions. Patients are followed at Days 14, 28, 56, 80, 180, and 360.

Clinical Study Identifier: NCT00010348

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Ann Woolfrey

Fred Hutchinson Cancer Research Center
Seattle, WA United States
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Recruitment Status: Open

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