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Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000756
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

To determine the safety, tolerance, and feasibility of adoptive immunotherapy with autologous cytotoxic T-lymphocytes (CTLs) in HIV-infected patients with CD4 counts between 100 and 400; to evaluate the immunologic, virologic, and clinical changes for up to 24 weeks following infusion of study therapy.

Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors encoding HIV-1-specific proteins. Administration of these cytotoxic T lymphocytes (CTLs) may help prevent HIV disease progression.


Condition Intervention Phase
HIV Infections Drug: Lymphocytes, Activated Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 15
Study Completion Date: June 2002
Detailed Description:

Freshly isolated peripheral blood lymphocytes from HIV-1-seropositive individuals frequently lyse autologous HIV-1-expressing cells or autologous cells infected with vaccinia vectors encoding HIV-1-specific proteins. Administration of these cytotoxic T lymphocytes (CTLs) may help prevent HIV disease progression.

AMENDED 03/28/94:

Patients are not accrued at the 25 billion CTL dose. Instead, a third cohort receives three infusions of 1 billion CTL 5-8 weeks apart.

AMENDED 02/14/94:

Patients infused with 1 or 5 billion CTL will be reinfused with 1 billion CTL 6-12 months later, and then followed for up to 12 weeks after the reinfusion.

ORIGINAL DESIGN:

Fifteen patients whose cells show an HIV-specific cytotoxic T lymphocyte (CTL) response are infused with autologous, ex-vivo expanded CTLs at a dose of 1, 5, or 25 billion cells (five patients per dose level). If one to three patients at a given dose develop acute toxicity, an additional three patients will be entered at that dose. If four patients at any given dose develop acute toxicity, the next lower dose will be designated as the MTD (if four patients develop acute toxicity in the first cohort, the study will be terminated). Patients are evaluated during infusion and at 1, 2, 4, 8, and 24 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Approved antiretroviral therapy and/or prophylactic PCP therapy, provided there was no change in such therapy in the 4 weeks prior to study entry.
  • Other approved treatments for HIV-related diseases that are not known to affect cellular immune response.
  • G-CSF.
  • Erythropoietin.
  • Supportive care for acute therapy-related toxicity.

Patients must have:

  • HIV infection.
  • CD4 count 100 - 400 cells/mm3.
  • No current or previously documented AIDS-related opportunistic infection, malignancy, or encephalopathy other than mild Kaposi's sarcoma.
  • FEV1 > 70 percent, DLCO > 50 percent predicted for height and age (initial infusion only).
  • T cell lines with specific cytotoxicity against HIV-1.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Significant autoimmune disease.
  • Non-AIDS-associated malignancy.
  • Symptoms of cardiac disease.
  • Dyspnea on significant exertion.
  • Acute infiltrates on chest radiographs.

Patients with the following prior conditions are excluded:

  • History of significant arrhythmia, infarction, or heart failure.
  • History of a major psychiatric illness.

Prior Medication:

Excluded within 4 weeks prior to study entry:

  • Systemic immunosuppressive therapy (i.e., steroids, cyclosporine, chemotherapy, or alpha-interferon).
  • Therapy for acute infection, AIDS-related opportunistic infection, or malignancy.
  • Experimental AIDS therapy.

Prior Treatment:

Excluded:

  • Potentially immunosuppressive local therapy or radiation therapy for Kaposi's sarcoma within 4 weeks prior to study entry.

Current substance abuse.

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00000756


Locations
United States, Massachusetts
New England Med Ctr / Tufts Univ
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: J Lieberman
Study Chair: H Standiford
Study Chair: D Stein
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000756     History of Changes
Other Study ID Numbers: DATRI 006
11736 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
T-Lymphocytes
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunotherapy, Adoptive
Transplantation, Autologous

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases