Autologous Dendritic Cell Vaccine in HIV1 Infection
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ClinicalTrials.gov Identifier: NCT00510497 |
Recruitment Status
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Completed
First Posted
: August 2, 2007
Results First Posted
: April 4, 2016
Last Update Posted
: June 16, 2016
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Sponsor:
Sharon Riddler
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sharon Riddler, University of Pittsburgh
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Tracking Information | ||||
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First Submitted Date ICMJE | August 1, 2007 | |||
First Posted Date ICMJE | August 2, 2007 | |||
Results First Submitted Date | January 12, 2016 | |||
Results First Posted Date | April 4, 2016 | |||
Last Update Posted Date | June 16, 2016 | |||
Study Start Date ICMJE | July 2007 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine. [ Time Frame: 80 weeks ] AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
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Original Primary Outcome Measures ICMJE |
The primary endpoint is the safety and tolerability of autologous HIV-1 ApB DC Vaccine. [ Time Frame: 80 weeks ] | |||
Change History | Complete list of historical versions of study NCT00510497 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART) [ Time Frame: at the end of 12 weeks treatment interruption ] Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption
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Original Secondary Outcome Measures ICMJE |
Virologic efficacy (HIV-1 viral load at end of ATI minus viral load prior to ART) and immunologic response (number of T cells reactive against the vaccine as measured by both ELISPOT assay, ICC Staining, and lymphocyte proliferation assay by CFSE) [ Time Frame: at the end of 12 weeks treatment interruption ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Autologous Dendritic Cell Vaccine in HIV1 Infection | |||
Official Title ICMJE | Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells | |||
Brief Summary | This study aims to look at the safety and tolerability of immunization with dendritic cell vaccine prepared using the patient's own cells and virus. It also aims to explore the virologic efficacy of the vaccine as determined by a decrease in the viral load 12 weeks after analytic treatment interruption. | |||
Detailed Description | This is a phase I/II, open label, single-arm, single-site clinical trial designed to evaluate the safety and antiviral activity of the ApB DC vaccine, a therapeutic vaccine derived from autologous dendritic cells loaded with autologous HIV-1 infected apoptotic cells. The study will be conducted in three phases. The first is the pre-vaccination phase that includes study entry, isolation of autologous virus, and initiation of antiretroviral therapy. Once the patient's viral load has been suppressed to undetectable levels (<50 copies/mL) and sufficient virus has been isolated, the second phase will begin. This includes leukapheresis in order to harvest monocytes and lymphocytes necessary for vaccine preparation. Three vaccine doses will be administered subcutaneously every other week. Six weeks after the last vaccination, the third phase, analytic treatment interruption (ATI) phase, will begin. A fourth, booster dose of vaccine will be given two weeks after the start of treatment interruption. The treatment interruption will be continued for twelve weeks after which the primary HIV provider will decide whether or not antiretroviral therapy should be restarted. CD4 and viral load will be closely monitored throughout the study especially during treatment interruption. Follow-up will be continued for 24 weeks after the 12-week treatment interruption. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | |||
Intervention ICMJE | Biological: Autologous HIV-1 ApB DC Vaccine
Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption |
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Study Arms | Experimental: Autologous HIV-1 ApB DC Vaccine
Subjects who will receive ApB Dendritic cell vaccine
Intervention: Biological: Autologous HIV-1 ApB DC Vaccine |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
11 | |||
Original Estimated Enrollment ICMJE |
24 | |||
Actual Study Completion Date | September 2012 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00510497 | |||
Other Study ID Numbers ICMJE | Riddler 055794 5U19AI055794 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sharon Riddler, University of Pittsburgh | |||
Study Sponsor ICMJE | Sharon Riddler | |||
Collaborators ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Investigators ICMJE |
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PRS Account | University of Pittsburgh | |||
Verification Date | May 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |