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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00110578 |
Effective, suppressive treatment for HIV infected patients can be a major challenge because HIV progressively destroys their immune systems. CD8 cells isolated from a patient's blood and grown in large numbers in the laboratory may increase a patient's immune system response to HIV. The purpose of this study is to determine if CD8 cells will provide effective antiviral activity against HIV when transplanted back in large numbers into HIV infected patients.
Study hypothesis: There are specific cells in the immune system that recognize and can kill HIV-infected cells.
Condition | Intervention | Phase |
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HIV Infections |
Procedure: Adoptive transfer of HIV-specific CD8+ T cells Drug: Aldesleukin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Antiviral Efficacy of Cellular Adoptive Immunotherapy With Autologous CD8+ HIV-Specific Cytotoxic T Cells Combined With Interleukin-2 For HIV Seropositive Individuals |
Estimated Enrollment: | 24 |
Study Start Date: | September 1998 |
Estimated Study Completion Date: | April 2005 |
The function of CD8 cells in the human body is to kill infected target cells, such as HIV infected cells. Recent data suggest that intravenous administration of HIV-specific CD8 cells is safe, augments host immunity, and mediates a dramatic reduction in circulating HIV-infected CD4 cells.
However, the observed antiviral effects are transient, and HIV infected CD4 cells re-emerge as the number of self CD8 cells declines. Augmenting CD8 cell response to HIV by immunotherapy with CD8 cells may be a useful addition to drug therapy if the infused CD8 cells can survive long-term in vivo.
Administration of interleukin-2 (also known as aldesleukin or IL-2), a naturally occurring cytokine, has been proposed as a way to maintain the number of CD8 cells. This study will evaluate the safety and efficacy of immunotherapy with HIV-specific CD8 cells in HIV infected patients. Additionally, this study will determine if aldesleukin injections improve the persistence of self CD8 transplants and the duration of antiviral activity without severe toxicity.
This study will last 18 months. CD8 cells will be isolated from the blood of HIV infected patients; the cells will be allowed to multiply in the laboratory, and patients will receive back their CD8 cells. Patients will receive up to 3 infusions of self CD8 cells. On Day 0, patients will receive their first infusion of CD8 cells. On Day 7, patients will receive their second infusion of CD8 cells; this infusion will be followed by 14 days of aldesleukin administered daily by injection under the skin. Patients with less than a Grade 2 toxicity will receive a third infusion of CD8 cells; this infusion will be followed by 21 days of aldesleukin.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for All Participants:
Inclusion Criteria for Treatment-Experienced Participants:
Inclusion Criteria for Treatment-Naive Participants:
Exclusion Criteria:
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 | |
University of Washington (UW) | |
Seattle, Washington, United States, 98122 |
Principal Investigator: | Stanley Riddell, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | 5U01AI054334-02, AI54334 |
Study First Received: | May 10, 2005 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00110578 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Treatment Naive Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-HIV Agents Aldesleukin Anti-Retroviral Agents Interleukin-2 |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Immune System Diseases Antineoplastic Agents Acquired Immunodeficiency Syndrome Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Aldesleukin Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |