NCT00510497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed
Last Updated

November 6, 2025

Status Verified

October 1, 2025

Enrollment Period

5.2 years

First QC Date

August 1, 2007

Results QC Date

January 12, 2016

Last Update Submit

October 27, 2025

Conditions

HIV Infections

Keywords

dendritic celltherapeutic vaccineHIV-1apoptotic cellsPhase I/II

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.

    AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004

    80 weeks

Secondary Outcomes (1)

  • Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)

    at the end of 12 weeks treatment interruption

Study Arms (1)

Autologous HIV-1 ApB DC Vaccine

EXPERIMENTAL

Subjects who will receive ApB Dendritic cell vaccine

Biological: Autologous HIV-1 ApB DC Vaccine

Interventions

Autologous HIV-1 ApB DC VaccineBIOLOGICAL

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

Autologous HIV-1 ApB DC Vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Macatangay BJ, Riddler SA, Wheeler ND, Spindler J, Lawani M, Hong F, Buffo MJ, Whiteside TL, Kearney MF, Mellors JW, Rinaldo CR. Therapeutic Vaccination With Dendritic Cells Loaded With Autologous HIV Type 1-Infected Apoptotic Cells. J Infect Dis. 2016 May 1;213(9):1400-9. doi: 10.1093/infdis/jiv582. Epub 2015 Dec 8.

    PMID: 26647281RESULT

  • Whiteside TL, Piazza P, Reiter A, Stanson J, Connolly NC, Rinaldo CR Jr, Riddler SA. Production of a dendritic cell-based vaccine containing inactivated autologous virus for therapy of patients with chronic human immunodeficiency virus type 1 infection. Clin Vaccine Immunol. 2009 Feb;16(2):233-40. doi: 10.1128/CVI.00066-08. Epub 2008 Nov 26.

    PMID: 19038780RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Sharon A. Riddler, MD, MPH
Organization
University of Pittsburgh
riddler@pitt.edu
412-383-1675

Study Officials

  • Sharon A Riddler, MD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 2, 2007

Study Start

July 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 6, 2025

Results First Posted

April 4, 2016

Record last verified: 2025-10

Locations

US(1)