Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510497
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2007-08-01
Brief Title:
Autologous Dendritic Cell Vaccine in HIV1 Infection
Sponsor:
Sharon Riddler
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase III Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous Inactivated HIV-1 Infected Apoptotic Cells
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to look at the safety and tolerability of immunization with dendritic cell vaccine prepared using the patients 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 III 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 patients viral load has been suppressed to undetectable levels 50 copiesmL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U19AI055794 | NIH | None | httpsreporternihgovquickSearch5U19AI055794 |