Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Blood Cancer, Infectious Disease, HIV / AIDS, Lymphoma, Women's Studies, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:December 2009

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Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV

This phase II trial studies the immune response after stem cell transplant in human
immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer).
Studying samples of blood from HIV-positive patients with cancer in the laboratory may help
doctors learn more about changes that occur in the immune system after stem cell transplant.

PRIMARY OBJECTIVES:

I. Examine the development of donor-derived HIV-1-specific immune response following
hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+
patients.

II. Examine the affect of HCT on the pool of latently infected cluster of differentiation
(CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.

OUTLINE:

Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at
days +90, +180, +365, and +730, and then annually thereafter as feasible.

Inclusion Criteria:

- HIV positive

- Treatment with highly active antiretroviral therapy (HAART) for at least 1 month

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

- Hematologic malignancy associated with a poor prognosis or other diagnosis for which
hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is
indicated

- Approval for allogenic regimen given at Patient Care Conference

- DONOR: Autologous or allogeneic gene modified cells allowed

Exclusion Criteria:

- A medical history of noncompliance with HAART or medical therapy

- Inability to provide informed consent

- DONOR: Allogeneic donors must not have HIV infection
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Ann E. Woolfrey
Phone: 206-667-4453
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mi
from
Seattle, WA
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