A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects (PARC002)
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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 May 19, 2013