Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
NCT ID: NCT00058734
Last Updated: 2007-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2000-11-30
Brief Summary
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Detailed Description
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HIV infected and HIV uninfected individuals in this study will receive one shot of dendritic cells alone followed by three monthly shots of dendritic cells plus vaccine. We will monitor the immune responses to the peptide vaccine during this time period. After completing the vaccinations, HIV infected patients will stop their HIV medications and their immune status (CD4 count) and viral load will be monitored closely over 12 weeks.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Dendritic Cells Pulsed with HIV antigens
Eligibility Criteria
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Inclusion Criteria
* CD4 cell count of 400 cells/mm3 or greater at study entry
* If HIV infected, initiated anti-HIV medicines within 120 days of infection
* If HIV infected, HIV viral load \< 50 copies/ml for at least 3 months prior to study entry
* Current medication regimen for at least 3 months prior to study entry
* A particular blood type (HLA-A\*0201)
* Acceptable methods of contraception
Exclusion Criteria
* On other immune-based therapy (e.g., interleukin-2, alpha interferon, immunoglobulin, thalidomide) within 30 days prior to study entry
* Megesterol acetate within 30 days prior to study entry
* Immunization within 4 weeks of study entry
* If hepatitis B virus (HBV) uninfected and at high risk for HBV infection, the patient will not be eligible until he or she has completed an HBV vaccine series.
* Unstable or severe medical condition, including active opportunistic infection requiring treatment
* History of Hashimoto's thyroiditis
* Cancer requiring chemotherapy within 6 months prior to study entry
* History of radiation therapy to axillary lymph nodes
* Significant laboratory abnormalities at study entry
* Pregnant or breastfeeding
* History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, scleroderma, mixed connective tissue disorder)
* Allergy to gentamicin, tobramycin, streptomycin, or amikacin
18 Years
60 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Nina Bhardwaj, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
New York University
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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