A Pilot Study Involving Administration of Combination Anti-Retroviral Therapy and Transplantation of HLA-Matched Sibling Peripheral Blood Stem Cells or Partially HLA-Matched Unrelated Umbilical Cord Blood In Adults With HIV Infection and Hematologic Malignancies
OBJECTIVES: I. Determine the feasibility and safety of combination antiretroviral therapy
followed by HLA matched sibling peripheral blood stem cell or unrelated umbilical cord blood
transplants in HIV infected adults with hematologic malignancies. II. Measure the effects of
this treatment on HIV viral burden in the serum and tissues of these patients. III. Measure
immune reconstitution following treatment in this patient population.
OUTLINE: Patients receive a combination of 3 antiretroviral agents beginning at least 3
weeks prior to the initiation of the myeloablative conditioning regimen. The antiretroviral
agents are discontinued on days -5 to -1 prior to transplant. Beginning on day 0 the
antiretroviral agents are restarted and continue indefinitely. Patients who are given
umbilical cord blood (UCB) transplants undergo collection of autologous peripheral blood
stem cells (PBSC) prior to the myeloablative conditioning regimen in case there is UCB graft
failure. Prior to PBSC or UCB transplantation on day 0, all patients receive a myeloablative
conditioning regimen. The conditioning regimen consists of total body irradiation twice a
day on days -9 to -5 and melphalan IV over 60 minutes on days -4 to -2. Patients receiving
UCB transplant also receive anti-thymocyte globulin over 6 hours on days -3 to -1. Patients
are followed every 3 months for 3 years, then annually for the next 3 years.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 2 years.
Primary Purpose: Treatment
Clayton Smith, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|