Autologous Dendritic Cell Vaccine in HIV1 Infection

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sharon Riddler, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00510497
First received: August 1, 2007
Last updated: December 9, 2013
Last verified: December 2013

August 1, 2007
December 9, 2013
July 2007
September 2012   (final data collection date for primary outcome measure)
The primary endpoint is the safety and tolerability of autologous HIV-1 ApB DC Vaccine. [ Time Frame: 80 weeks ] [ Designated as safety issue: Yes ]
The primary endpoint is the safety and tolerability of autologous HIV-1 ApB DC Vaccine. [ Time Frame: 80 weeks ]
Complete list of historical versions of study NCT00510497 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Autologous Dendritic Cell Vaccine in HIV1 Infection
Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
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
Experimental: I
Subjects who will receive ApB Dendritic cell vaccine
Intervention: Biological: Autologous HIV-1 ApB DC Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510497
Riddler 055794, 5U19AI055794
Yes
Sharon Riddler, University of Pittsburgh
Sharon Riddler
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Sharon A Riddler, MD MPH University of Pittsburgh
University of Pittsburgh
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP