A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects (PARC002)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rajesh T. Gandhi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833781
First received: January 29, 2009
Last updated: April 25, 2012
Last verified: April 2012

January 29, 2009
April 25, 2012
August 2009
December 2013   (final data collection date for primary outcome measure)
The safety and tolerability of mRNA-transfected autologous dendritic cell vaccine. [ Time Frame: After each vaccination. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00833781 on ClinicalTrials.gov Archive Site
Immune response to the vaccine. [ Time Frame: Week 4 and after the final vaccination. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
A Pilot, Double-blind, Placebo-controlled, Randomized Clinical Trial of mRNA-transfected Autologous Dendritic Cells in Subjects With Well-controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy

The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • HIV-1 Infection
  • HIV Infections
  • Biological: mRNA-transfected autologous dendritic cells
    Injections will be administered intradermally at weeks 0, 2, 6 and 10.
    Other Name: mRNA-transfected autologous dendritic cells
  • Biological: Autologous dendritic cells not transfected with mRNA.
    Injections will be administered intradermally at weeks 0, 2, 6 and 10.
    Other Name: Autologous dendritic cells not transfected with mRNA.
  • Active Comparator: 1
    mRNA-transfected autologous dendritic cell vaccine.
    Intervention: Biological: mRNA-transfected autologous dendritic cells
  • Placebo Comparator: 2
    Dendritic cell vaccine without transfected mRNA.
    Intervention: Biological: Autologous dendritic cells not transfected with mRNA.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 positive
  • CD4+ T Cell count >200
  • Undetectable HIV viral load for 6 months prior to screening
  • On antiretroviral treatment for 12 months prior to screening

Exclusion Criteria:

  • Hepatitis C positive
  • Detectable HIV viral load within 6 months prior to study entry
  • Females who are pregnant or nursing
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833781
2008p001577, R01-AI066992-04, DAIDS-ES ID 10731
Yes
Rajesh T. Gandhi, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Rajesh Gandhi, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP