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

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive, Treatment Experienced
Eligibility 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
Sites / Locations
- Fred Hutchinson Cancer Research Center
- University of Washington (UW)