Autologous Dendritic Cell Vaccine in HIV1 Infection

This study has been completed.

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Sharon Riddler, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00510497

First received: August 1, 2007

Last updated: May 12, 2016

Last verified: May 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

August 1, 2007

Last Updated Date

May 12, 2016

Start Date ^ICMJE

July 2007

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine. [ Time Frame: 80 weeks ] [ Designated as safety issue: Yes ]

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

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

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 ] [ Designated as safety issue: No ]

Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption

Original Secondary Outcome Measures ^ICMJE

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

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

Experimental: Autologous HIV-1 ApB DC Vaccine

Subjects who will receive ApB Dendritic cell vaccine

Intervention: Biological: Autologous HIV-1 ApB DC Vaccine

Publications *

* 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

Enrollment ^ICMJE

Completion Date

September 2012

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.

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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