Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer

PRIMARY OBJECTIVES:

I. To determine the safety of treating high-risk HIV1-infected patients with 200 centigray
(cGy) TBI plus post-transplant MMF/CSP.

II. To determine whether 200 cGy TBI plus post-transplant MMF/CSP results in stable mixed
donor lymphocyte chimerism (5-95% donor cluster of differentiation [CD]3) in high-risk human
immunodeficiency virus (HIV)-1 infected patients.

SECONDARY OBJECTIVES:

I. To define the kinetics of immune reconstitution following a non-lethal conditioning
regimen in HIV1-infected patients.

II. To determine the effect of a non-lethal conditioning regimen on viral load.

OUTLINE:

CONDITIONING REGIMEN: Patients receive fludarabine intravenously (IV) over 2 hours on days
-4, -3, and -2. Patients undergo TBI on day 0.

TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or
peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine IV or orally (PO) 2 to 3 times daily on
days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of
graft-vs-host disease (GVHD). Beginning within 6 hours after transplantation, patients also
receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in
the absence of GVHD.

After completion of study treatment, patients are followed up for at least 1 year.

Inclusion Criteria:

- Patients with hematologic malignancy, lymphoma or other HIV-associated malignancy are
eligible provided these criteria are met:

- The malignancy is in complete remission or very good partial remission, defined
as a significant reduction of disease with therapy and no evidence for continued
tumor growth in the case of lymphoma or solid tumors

- Highly active antiretroviral therapy (HAART) is initiated within one month of
hematopoietic cell transplant

- Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on
HAART therapy

- CD4 count is allowed to be > 100 cells/ul

- HIV infected patients without malignancy who have failed HAART are eligible provided
that these criteria are met:

- They have been treated with more than one regimen of HAART for a total of at
least 6 months duration

- The viral load is < 50 copies/ml plasma

- The CD4 count < 100 cells/ul

- DONOR: Human leukocyte antigen (HLA) genotypically/phenotypically identical donor; if
more than one HLA-identical sibling is available, priority will be given to donors
matched for cytomegalovirus (CMV) status, ABO titer, and sex

- Peripheral blood stem cells will be collected from donors greater than 12 years
of age

- Bone marrow will be collected from donors less than 12 years of age

- DONOR: HLA phenotypically identical unrelated donor; match grades allowed:

- Match grade 1: Matched at allele level for HLA-A, B, C, DRB1, and DQB1

- Match grade 2.1: Single allele disparity for HLA-A, B, C, DRB1, and DQB1

Exclusion Criteria:

- Positive serology for toxoplasma gondii on treatment or with evidence of active
infection

- Patients with other disease or organ dysfunction that would limit survival to less
than 30 days

- Patients with medical history of noncompliance with HAART or medical therapy

- DONOR: Donors for whom medical or psychologic reasons would make donor procedure
intolerable

- DONOR: Marrow donors who have increased anesthetic risk

- DONOR: Donors who are HIV positive

- DONOR: Age > 75 years