A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects (PARC002)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00833781 |
Recruitment Status :
Completed
First Posted : February 2, 2009
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
|
Sponsor:
Massachusetts General Hospital
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Rajesh T. Gandhi, MD, Massachusetts General Hospital
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Conditions |
HIV-1 Infection HIV Infections |
Interventions |
Biological: mRNA-transfected autologous dendritic cells Biological: autologous dendritic cells with no mRNA transfection |
Enrollment | 15 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | mRNA-transfected Autologous Dendritic Cell Vaccine. | Autologous Dendritic Cells Without Transfected mRNA. |
---|---|---|
![]() |
mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
Dendritic cell vaccine without transfected mRNA. Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
Period Title: Overall Study | ||
Started | 10 | 5 |
Completed | 10 | 5 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | mRNA-transfected Autologous Dendritic Cell Vaccine. | Autologous Dendritic Cells Without Transfected mRNA. | Total | |
---|---|---|---|---|
![]() |
mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
Dendritic cell vaccine without transfected mRNA. Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 10 | 5 | 15 | |
![]() |
[Not Specified]
|
|||
Age, Continuous
Median (Full Range) Unit of measure: Years |
||||
Number Analyzed | 10 participants | 5 participants | 15 participants | |
44
(33 to 55)
|
49
(42 to 52)
|
46.7
(33 to 55)
|
||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 10 participants | 5 participants | 15 participants | |
Female |
3 30.0%
|
0 0.0%
|
3 20.0%
|
|
Male |
7 70.0%
|
5 100.0%
|
12 80.0%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
United States | Number Analyzed | 10 participants | 5 participants | 15 participants |
10 | 5 | 15 |
Outcome Measures
Adverse Events
Limitations and Caveats
The trial size is small, precluding detection of small effect sizes.
More Information
Results Point of Contact
Name/Title: | Dr. Rajesh Gandhi |
Organization: | Mass General Hospital |
Phone: | 617-724-9690 |
EMail: | rgandhi@partners.org |
Responsible Party: | Rajesh T. Gandhi, MD, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00833781 |
Other Study ID Numbers: |
2008p001577 R01AI066992-04 ( U.S. NIH Grant/Contract ) DAIDS-ES ID 10731 ( Other Identifier: DAIDS ) |
First Submitted: | January 29, 2009 |
First Posted: | February 2, 2009 |
Results First Submitted: | October 15, 2015 |
Results First Posted: | March 8, 2016 |
Last Update Posted: | March 8, 2016 |