Autologous Dendritic Cell Vaccine in HIV1 Infection

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sharon Riddler, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00510497
First received: August 1, 2007
Last updated: May 12, 2016
Last verified: May 2016
Results First Received: January 12, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Biological: Autologous HIV-1 ApB DC Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Autologous HIV-1 ApB DC Vaccine

Subjects who will receive ApB Dendritic cell vaccine

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


Participant Flow:   Overall Study
    Autologous HIV-1 ApB DC Vaccine  
STARTED     11  
COMPLETED     8  
NOT COMPLETED     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
11 particpants were enrolled but one received no study vaccines and was withdrawn and not included in any analyses.

Reporting Groups
  Description
Autologous HIV-1 ApB DC Vaccine

Subjects who will receive ApB Dendritic cell vaccine

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


Baseline Measures
    Autologous HIV-1 ApB DC Vaccine  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Age  
[units: years]
Median (Full Range)
  37.9  
  (20 to 54)  
Gender  
[units: participants]
 
Female     0  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.   [ Time Frame: 80 weeks ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sharon A. Riddler, MD, MPH
Organization: University of Pittsburgh
phone: 412-383-1675
e-mail: riddler@pitt.edu


Publications of Results:

Responsible Party: Sharon Riddler, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00510497     History of Changes
Other Study ID Numbers: Riddler 055794
5U19AI055794 ( US NIH Grant/Contract Award Number )
Study First Received: August 1, 2007
Results First Received: January 12, 2016
Last Updated: May 12, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: University of Pittsburgh Data Safety and Monitoring Board