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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sharon A Riddler, MD MPH | (412)647-6710 | riddler@dom.pitt.edu |
| Contact: Christine Tripoli, BSN | (412)647-8125 | tripolica@upmc.edu |
| 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 | |
| Principal Investigator: | Sharon A Riddler, MD MPH | University of Pittsburgh |
More Information
| 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 |
|
dendritic cell therapeutic vaccine HIV-1 |
apoptotic cells Phase I/II HIV-1 |
|
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 |