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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aldesleukin

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 entry

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