Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer
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ClinicalTrials.gov Identifier: NCT00968630 |
Recruitment Status
:
Completed
First Posted
: August 31, 2009
Last Update Posted
: May 24, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hematopoietic and Lymphoid Cell Neoplasm HIV Infection | Other: Laboratory Biomarker Analysis Procedure: Leukapheresis | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution After Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected With HIV |
Actual Study Start Date : | December 17, 2009 |
Actual Primary Completion Date : | March 17, 2017 |
Actual Study Completion Date : | March 17, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (HIV-specific immune reconstitution after HCT)
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.
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Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Leukapheresis
Undergo leukapheresis
Other Names:
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- Quantification of donor-derived HIV-1-specific immune responses following HCT [ Time Frame: Up to 1 year ]HIV-1 specific immune responses will be evaluated in samples collected before and after HCT. These results will be used descriptively.
- Quantification of latently infected CD4+ cells in HIV+ patients [ Time Frame: Up to 7 years ]The overall measure of efficacy will be the log change in HIV-1 latent reservoir, measured as infectious units per million.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968630
United States, Washington | |
Fred Hutch/University of Washington Cancer Consortium | |
Seattle, Washington, United States, 98109 |
Principal Investigator: | Ann Woolfrey | Fred Hutch/University of Washington Cancer Consortium |
Responsible Party: | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00968630 History of Changes |
Other Study ID Numbers: |
2212.00 NCI-2009-01244 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2212 2212.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) P01CA018029 ( U.S. NIH Grant/Contract ) P30CA015704 ( U.S. NIH Grant/Contract ) U19AI096111 ( U.S. NIH Grant/Contract ) |
First Posted: | August 31, 2009 Key Record Dates |
Last Update Posted: | May 24, 2017 |
Last Verified: | May 2017 |
Additional relevant MeSH terms:
HIV Infections Hematologic Neoplasms Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms by Site Neoplasms Hematologic Diseases |