Safety and Effectiveness of Immunotherapy With Autologous HIV-Specific CD8 Cells in HIV Infected Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00110578

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Starts

1998-09-01

Expected to finish

2005-04-01

Last updated by the study team

2008-08-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• University of Washington (UW) — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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