Full Text View
Tabular View
No Study Results Posted
Related Studies
Autologous Dendritic Cell Vaccine in HIV1 Infection
This study is currently recruiting participants.
Verified by University of Pittsburgh, October 2008
First Received: August 1, 2007   Last Updated: October 16, 2008   History of Changes
Sponsor: University of Pittsburgh
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00510497
  Purpose

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 Intervention Phase
HIV Infections
Biological: Autologous HIV-1 ApB DC Vaccine
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary endpoint is the safety and tolerability of autologous HIV-1 ApB DC Vaccine. [ Time Frame: 80 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: July 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Experimental
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510497

Contacts
Contact: Sharon A Riddler, MD MPH (412)647-6710 riddler@dom.pitt.edu
Contact: Christine Tripoli, BSN (412)647-8125 tripolica@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Carol Oriss, RN, BSN     412-647-8125     orissca@upmc.edu    
Principal Investigator: Sharon A Riddler, MD MPH            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sharon A Riddler, MD MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh ( Sharon Riddler )
Study ID Numbers: Riddler 055794
Study First Received: August 1, 2007
Last Updated: October 16, 2008
ClinicalTrials.gov Identifier: NCT00510497     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration;   United States: University of Pittsburgh Data Safety and Monitoring Board

Keywords provided by University of Pittsburgh:
dendritic cell
therapeutic vaccine
HIV-1
apoptotic cells
Phase I/II
HIV-1

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010