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

NCT00000756 | Completed Phase 1

• 2 other identifiers: DATRI 00611736
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

T-Lymphocytes; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Immunotherapy, Adoptive; Transplantation, Autologous

Interventions

Lymphocytes, Activated DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

New England Med Ctr / Tufts Univ

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Lieberman J, Skolnik PR, Parkerson GR 3rd, Fabry JA, Landry B, Bethel J, Kagan J. Safety of autologous, ex vivo-expanded human immunodeficiency virus (HIV)-specific cytotoxic T-lymphocyte infusion in HIV-infected patients. Blood. 1997 Sep 15;90(6):2196-206.

  PMID: 9310470 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Lymphocyte Count

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Leukocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• J Lieberman

  STUDY CHAIR

• H Standiford

  STUDY CHAIR

• D Stein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 2002
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (1)