Completed

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

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What is being tested

Lymphocytes, Activated

Drug
Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleEvaluation 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 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
15 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
New England Med Ctr / Tufts UnivBoston, United StatesSee the location

CompletedOne Study Center