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Safety and Antiviral Efficacy of Cellular Adoptive Immunotherapy With Autologous CD8+ HIV-Specific Cytotoxic T Cells Combined With Interleukin-2 For HIV Seropositive Individuals

Phase 1
18 Years
65 Years
Not Enrolling
HIV Infections

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Trial Information

Safety and Antiviral Efficacy of Cellular Adoptive Immunotherapy With Autologous CD8+ HIV-Specific Cytotoxic T Cells Combined With Interleukin-2 For HIV Seropositive Individuals

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

Inclusion Criteria

Inclusion Criteria for All Participants:

- HIV infected

- CD4 count greater than 200 cells/mm3 at study entry

- Absolute neutrophil count greater than 1000 cells/mm3

- Willing to take Pneumocystis prophylaxis, if indicated

- Willing to comply with study requirements

- Willing to forgo other experimental therapy during the 26-week study period

- Willing to use acceptable forms of contraception

Inclusion Criteria for Treatment-Experienced Participants:

- Currently receiving treatment with an FDA-approved or expanded access antiretroviral
agent (or combinations thereof) at a stable dose for at least 24 weeks prior to study

Inclusion Criteria for Treatment-Naive Participants:

- Have not received antiretroviral therapy for 6 months prior to study entry

Exclusion Criteria:

- Treatment with other immunomodulatory therapies (interferon, HIV vaccines,
intravenous immunoglobulin), pentoxifylline, cancer chemotherapy, radiation therapy,
or other investigational agents

- Past or present infection with mycobacterium avium complex, toxoplasmosis,
cryptococcus, or cytomegalovirus (including retinitis)

- Active opportunistic infection at study entry or serious systemic infection requiring
chronic maintenance or suppressive therapy

- Lymphoma, symptomatic visceral Kaposi's sarcoma, or any malignancy expected to
require systemic therapy

- Serious psychological or emotional disorder that would affect ability to comply with
study requirements or that would be exacerbated by protocol participation

- Alcohol or drug use, abuse, or dependence that, in the opinion of the investigator,
would interfere with the study

- Estimated life expectancy of less than 4 months

- Abnormal neurocognitive examination

- Significant abnormality on electrocardiogram or chest radiograph

- Inability to generate CD8+ HIV-specific cytotoxic T cell clones

- Previously treated in FHCRC Protocol #827.1

- Pregnancy or breastfeeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of administering CD8+ HIV-specific CTL clones followed by subcutaneous IL-2 (Proleukin, Chiron) daily for up to 21 days

Principal Investigator

Stanley Riddell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 1998

Completion Date:

April 2005

Related Keywords:

  • HIV Infections
  • Treatment Naive
  • Treatment Experienced
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Washington (UW) Seattle, Washington  98122