Phase 2
Completed N=15
A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
HIV-1 Infection · HIV Infections
Source: ClinicalTrials.gov NCT00833781 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Safety of the DC Vaccine (as Measured by Frequency of Adverse Events) — 0; 0 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of the DC Vaccine (as Measured by Frequency of Adverse Events) |
0; 0 | — |
| PRIMARY Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef |
1.06; 1.058; 1.15; 1.021 | — |
| SECONDARY T Cell Proliferation |
2.465; 0.717; 2.292; 0.363 | — |
| SECONDARY IL2 and IFN Gamma Production |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00833781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.