A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | December 2013 |
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.
vaccine is safe, well tolerated, and whether it can strengthen the immune system's response
to HIV.
This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination
is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.
is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.
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
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