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A Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 cells/mm3



A Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 cells/mm3

For Condition: HIV Infections
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To define the safety and efficacy of sibling-supplied, HIV antigen-pulsed dendritic cells in increasing the immune response in HIV-infected patients. Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus.
Details: Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus. Dendritic cells from an HIV-negative sibling are obtained and treated with various viral proteins (HIV vaccines) or immunomodulators. The treated dendritic cells are infused into the HIV-infected patient monthly for 6 months. Siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. Patients are screened over 3 months prior to study entry.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HLA A2+. - Same cell type as donor sibling. - CD4 count > 350 cells/mm3. - HIV asymptomatic status. - No HIV antivirals during study. - Normal labs and chest x-ray. Donor siblings must have: - HLA A2+. - HIV negativity. - Ability to donate cells on multiple occasions. - Negative status for hepatitis B and C. Exclusion Criteria Concurrent Medication: Excluded: - Antiviral therapy (unless CD4 count declines to < 350 cells/mm3). Prior Medication: Excluded: - Antiviral therapy within 90 days prior to study entry.
Total Enrollment: 

Location and Contact Information:

Stanford Univ School of Medicine
Stanford,  California,  943055107
United States
 


Additional Information:
Study ID Numbers:  SPIRAT 1; 
Study Start Date: 
Record last reviewed: April 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001064

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2. Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine

3. Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine

4. Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

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