Autologous Dendritic Cell Vaccine in HIV1 Infection

HIV Infections Clinical Trial

Official title:

Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510497
• Other study ID #: Riddler 055794
• Secondary ID: 5U19AI055794
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 1, 2007
• Last updated: December 9, 2013
• Start date: July 2007
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationUnited States: University of Pittsburgh Data Safety and Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sharon Riddler	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the safety and tolerability of autologous HIV-1 ApB DC Vaccine.		80 weeks	Yes
Secondary	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)		at the end of 12 weeks treatment interruption	No