A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
NCT ID: NCT00833781
Last Updated: 2016-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2009-08-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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mRNA-transfected dendritic cells
Participants in this arm/group received mRNA-transfected autologous dendritic cells
mRNA-transfected autologous dendritic cells
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Dendritic cells without mRNA
Participants in this arm/group received autologous dendritic cells with no mRNA transfection
autologous dendritic cells with no mRNA transfection
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Interventions
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mRNA-transfected autologous dendritic cells
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
autologous dendritic cells with no mRNA transfection
Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CD4+ T Cell count \>200
* Undetectable HIV viral load for 6 months prior to screening
* On antiretroviral treatment for 12 months prior to screening
Exclusion Criteria
* Detectable HIV viral load within 6 months prior to study entry
* Females who are pregnant or nursing
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Rajesh T. Gandhi, MD
Director of Education
Principal Investigators
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Rajesh Gandhi, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Infectious Disease Unit; Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Gandhi RT, Kwon DS, Macklin EA, Shopis JR, McLean AP, McBrine N, Flynn T, Peter L, Sbrolla A, Kaufmann DE, Porichis F, Walker BD, Bhardwaj N, Barouch DH, Kavanagh DG. Immunization of HIV-1-Infected Persons With Autologous Dendritic Cells Transfected With mRNA Encoding HIV-1 Gag and Nef: Results of a Randomized, Placebo-Controlled Clinical Trial. J Acquir Immune Defic Syndr. 2016 Mar 1;71(3):246-53. doi: 10.1097/QAI.0000000000000852.
Other Identifiers
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DAIDS-ES ID 10731
Identifier Type: OTHER
Identifier Source: secondary_id
2008p001577
Identifier Type: -
Identifier Source: org_study_id
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