Autologous Dendritic Cell Vaccine in HIV1 Infection

Tracking Information
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; (submitted: March 3, 2016)	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
Original Primary Outcome Measures ICMJE; (submitted: August 1, 2007)	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; (submitted: March 3, 2016)	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
Original Secondary Outcome Measures ICMJE; (submitted: August 1, 2007)	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
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
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
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
Publications *	Macatangay BJ, Riddler SA, Wheeler ND, Spindler J, Lawani M, Hong F, Buffo MJ, Whiteside TL, Kearney MF, Mellors JW, Rinaldo CR. Therapeutic Vaccination With Dendritic Cells Loaded With Autologous HIV Type 1-Infected Apoptotic Cells. J Infect Dis. 2016 May 1;213(9):1400-9. doi: 10.1093/infdis/jiv582. Epub 2015 Dec 8.; Whiteside TL, Piazza P, Reiter A, Stanson J, Connolly NC, Rinaldo CR Jr, Riddler SA. Production of a dendritic cell-based vaccine containing inactivated autologous virus for therapy of patients with chronic human immunodeficiency virus type 1 infection. Clin Vaccine Immunol. 2009 Feb;16(2):233-40. doi: 10.1128/CVI.00066-08. Epub 2008 Nov 26.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 9, 2013)	11
Original Estimated Enrollment ICMJE; (submitted: August 1, 2007)	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: 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.
Sex/Gender	Sexes Eligible for Study: All
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 )
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	Principal Investigator: Sharon A Riddler, MD MPH University of Pittsburgh
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