Skip to main content
OpenTrials
Completed

NCT Number: NCT00968630

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Leukapheresis

Procedure

Undergo leukapheresis

Other names: Leukocytopheresis, Therapeutic Leukopheresis

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2009
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.