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Autologous Dendritic Cell Vaccine in HIV1 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00510497
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : April 4, 2016
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sharon Riddler, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: Autologous HIV-1 ApB DC Vaccine Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells
Study Start Date : July 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous HIV-1 ApB DC Vaccine
Subjects who will receive ApB Dendritic cell vaccine
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed HIV-1 infection.
  • CD4 greater than or equal to 350 cells/mL within 8 weeks prior to study entry.
  • Plasma HIV-1 RNA level of 5000-100,000 copies/mL within 8 weeks prior to study entry.
  • Antiretroviral therapy naive.
  • Willingness to interrupt ART for at least 12 weeks.
  • Written informed consent.

Exclusion Criteria:

  • Treatment within 30 days prior to study entry with systemic steroids or other immunosuppressives, or any underlying disease which may require use of such medications during the study period.
  • Receipt of any vaccinations other than routine ones within 6 months of study entry
  • Pregnancy or breastfeeding
  • Previous or current CDC Category C event
  • Receipt of any investigational product within 12 weeks prior to study entry.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510497


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Sharon Riddler
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Sharon A Riddler, MD MPH University of Pittsburgh
More Information
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Publications of Results:

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Responsible Party: Sharon Riddler, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00510497    
Other Study ID Numbers: Riddler 055794
5U19AI055794 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2007    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: June 16, 2016
Last Verified: May 2016
Keywords provided by Sharon Riddler, University of Pittsburgh:
dendritic cell
therapeutic vaccine
HIV-1
apoptotic cells
Phase I/II
Additional relevant MeSH terms:
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Infections