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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


Phase 2
N/A
64 Years
Open (Enrolling)
Both
HIV Infections

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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 CenterSeattle, Washington  98109