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
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
HIV Infections
Biological: mRNA-transfected autologous dendritic cells
Biological: Autologous dendritic cells not transfected with mRNA.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The safety and tolerability of mRNA-transfected autologous dendritic cell vaccine. [ Time Frame: After each vaccination. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune response to the vaccine. [ Time Frame: Week 4 and after the final vaccination. ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
mRNA-transfected autologous dendritic cell vaccine.
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
Placebo Comparator: 2
Dendritic cell vaccine without transfected mRNA.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833781

Locations
United States, Massachusetts
Infectious Disease Unit; Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Rajesh Gandhi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Rajesh T. Gandhi, MD, Director of Education, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833781     History of Changes
Other Study ID Numbers: 2008p001577, R01-AI066992-04, DAIDS-ES ID 10731
Study First Received: January 29, 2009
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
HIV vaccine
Dendritic cells
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 11, 2014