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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 - Article


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Clinical Trial: 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

This study is currently recruiting patients.

Sponsored by: Fred Hutchinson Cancer Research Center
Information provided by: Office of Rare Diseases (ORD)

Purpose

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.

Condition Treatment or Intervention
HIV Infections
 Drug: Cyclosporine
 Drug: mycophenolate mofetil
 Procedure: Total Body Irradiation+Stem Cell or Bone Marrow Transplantation

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Safety Study

Further Study Details: 

Expected Total Enrollment:  20

Study start: November 2000

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. 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.

Eligibility

Ages Eligible for Study:  up to  64 Years,  Genders Eligible for Study:  Both

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--

--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

Location and Contact Information


Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States; Recruiting
Ann Woolfrey  206-667-4453 

Study chairs or principal investigators

Ann Woolfrey,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

Study ID Numbers:  199/15576; FHCRC-1410.00
Record last reviewed:  January 2005
Last Updated:  January 21, 2005
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010348
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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December 4, 2008



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