A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART)
EP1090
1 other identifier
interventional
32
1 country
2
Brief Summary
The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
Started Oct 2006
2 active sites
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
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedDecember 24, 2007
December 1, 2007
September 19, 2007
December 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Immunogenicity: defined as the effect of the vaccine on peripheral blood CD8 CTL responses, CD4 T cell counts, plasma HIV-1 RNA levels and clinical signs and symptoms.
six months
Interventions
Low dose
Eligibility Criteria
You may qualify if:
- HIV-1 Infection
- CD4 Tcell count \>350
- HIV-1 RNA levels to \<400 copies
- Negative HbsAg and anti-HCV antibody
You may not qualify if:
- Recent receipt of experimental HIV-1 vaccines
- Recent use of immunomodulatory agents
- Hypersensitivity or serious reactions to study vaccine components
- Active opportunistic infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epimmunelead
- Pharmexa A/Scollaborator
- Pharmexa-Epimmunecollaborator
Study Sites (2)
AIDS Research Alliance
West Hollywood, California, 90069, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 21, 2007
Study Start
October 1, 2006
Study Completion
April 1, 2008
Last Updated
December 24, 2007
Record last verified: 2007-12