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

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