Autologous Dendritic Cell Vaccine in HIV1 Infection
|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: NCT00510497|
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : April 4, 2016
Last Update Posted : June 16, 2016
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: Autologous HIV-1 ApB DC Vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Autologous HIV-1 ApB DC Vaccine
Subjects who will receive ApB Dendritic cell vaccine
Biological: Autologous HIV-1 ApB DC Vaccine
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
- Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine. [ Time Frame: 80 weeks ]AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
- Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART) [ Time Frame: at the end of 12 weeks treatment interruption ]Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510497
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Sharon A Riddler, MD MPH||University of Pittsburgh|
|Responsible Party:||Sharon Riddler, Associate Professor, University of Pittsburgh|
|Other Study ID Numbers:||
5U19AI055794 ( U.S. NIH Grant/Contract )
|First Posted:||August 2, 2007 Key Record Dates|
|Results First Posted:||April 4, 2016|
|Last Update Posted:||June 16, 2016|
|Last Verified:||May 2016|