Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
N/A
64 Years
Both
HIV Infections
Trial Information
Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
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.
Inclusion Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of human immunodeficiency virus-1 not responsive to highly active
antiretroviral therapy (HAART); treated with HAART for at least the past 6 months;
viral load less than 50 copies/mL plasma; CD4 count less than 100/mm3
- Lymphoma or other HIV-associated malignancy allowed with the following criteria:
malignancy is in complete remission or very good partial remission, defined as a
significant reduction of disease with therapy and no evidence of continued tumor
growth; viral load has decreased by at least 1.5 logs OR to less than 5,000 copies/mL
plasma while on HAART; CD4 count is allowed to be greater than 100/mm3
- HLA genotypically identical donor available (under 75 years of age)
--Prior/Concurrent Therapy--
- No concurrent growth factors during mycophenolate mofetil administration; concurrent
continuation of anti-retroviral therapy required
--Patient Characteristics--
- Life expectancy: At least 30 days
- Other: No positive serology for Toxoplasma gondii; no other disease or organ
dysfunction that would preclude survival; not pregnant or nursing; fertile patients
must use effective contraception during and for 1 year after study
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mortality due to infection, donor chimerism
Outcome Time Frame:
Days 14, 28, 56, 80, 180, and 360
Safety Issue:
Yes
Principal Investigator
Ann Woolfrey
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
199/15576
NCT ID:
NCT00010348
Start Date:
November 2000
Completion Date:
December 2015
Related Keywords:
- HIV Infections
- human immunodeficiency virus infection
- immunologic disorders and infectious disorders
- rare disease
- viral infection
- Acquired Immunodeficiency Syndrome
- HIV Infections
- Immunologic Deficiency Syndromes
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
