HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
Randomized Phase I Evaluation of Immunization With Highly Conserved HIV-1 Derived Peptides and Influenza Matrix Peptide in HIV-1-Infected Subjects on Highly Active Antiretroviral Therapy (HAART) Using Autologous Dendritic Cells Derived From Adherent Monocytic Precursors
1 other identifier
interventional
18
1 country
1
Brief Summary
This study will evaluate the safety of and immune responses to a dendritic cell vaccination for HIV-1 infection. The vaccine will be made from a patient's own cells combined with small fragments of HIV-1 (made synthetically in a laboratory). These cells will be administered back to the patient either into a vein (intravenously) or the skin (subcutaneously).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 21, 2003
CompletedFirst Posted
Study publicly available on registry
March 24, 2003
CompletedAugust 27, 2007
August 1, 2007
March 21, 2003
August 23, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of peptide pulsed, autologous, cultured dendritic cells
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 infection
- Current CD4 count more than 400/mm3
- HIV RNA less than 400 copies/ml
- Stable combination antiretroviral therapy for at least 4 weeks prior to study entry
- HLA A2.1 (to be tested at screening)
You may not qualify if:
- Prior HIV vaccine
- Systemic steroids or immunosuppressive drugs within 30 days of study entry
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh, Pitt Treatment Evaluation Unit
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon A. Riddler, MD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 21, 2003
First Posted
March 24, 2003
Study Start
February 1, 2003
Last Updated
August 27, 2007
Record last verified: 2007-08