Status:
COMPLETED
Safety and Effectiveness of Immunotherapy With Autologous HIV-Specific CD8 Cells in HIV Infected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 larg...
Detailed Description
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, augment...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00110578
Start Date
September 1 1998
End Date
April 1 2005
Last Update
August 8 2008
Active Locations (2)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
2
University of Washington (UW)
Seattle, Washington, United States, 98122