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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00010348
• Other study ID #: 199/15576
• Secondary ID: FHCRC-1410.00
• Status: Recruiting
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: May 13, 2009
• Start date: November 2000
• Est. completion date: December 2015

Study information

• Verified date: May 2009
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Cyclosporine
Oral or IV cyclosporine 2 to 3 times daily on Days -1 to 50
• Mycophenolate mofetil
Beginning within 6 hours of transplantation, oral mycophenolate mofetil every 12 hours until Day 27.

Procedure:
• Total body irradiation and stem cell or bone marrow transplantation
Assuming donor is available, total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation on Day 0.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality due to infection, donor chimerism		Days 14, 28, 56, 80, 180, and 360	Yes
Secondary	CD4, viral load		Days 14, 28, 56, 80, 180, and 360	Yes