Back to resultsA 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)
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EP1090
EP1090
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Human Immunodeficiency Virus, Vaccines, HIV Vaccines, Peptide, Peptide Vaccines, HIV 1
Eligibility Criteria
Inclusion Criteria:
- HIV-1 Infection
- CD4 Tcell count >350
- HIV-1 RNA levels to <400 copies
- Negative HbsAg and anti-HCV antibody
Exclusion Criteria:
- Recent receipt of experimental HIV-1 vaccines
- Recent use of immunomodulatory agents
- Hypersensitivity or serious reactions to study vaccine components
- Active opportunistic infections
Sites / Locations
- AIDS Research Alliance
- University of Colorado Health Sciences Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00532974
First Posted
September 19, 2007
Last Updated
December 19, 2007
Sponsor
Epimmune
Collaborators
Pharmexa A/S, Pharmexa-Epimmune
1. Study Identification
Unique Protocol Identification Number
NCT00532974
Brief Title
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)
Acronym
EP1090
Official Title
A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Epimmune
Collaborators
Pharmexa A/S, Pharmexa-Epimmune
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Human Immunodeficiency Virus, Vaccines, HIV Vaccines, Peptide, Peptide Vaccines, HIV 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
EP1090
Intervention Description
Low dose
Intervention Type
Biological
Intervention Name(s)
EP1090
Intervention Description
High dose
Primary Outcome Measure Information:
Title
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.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 Infection
CD4 Tcell count >350
HIV-1 RNA levels to <400 copies
Negative HbsAg and anti-HCV antibody
Exclusion Criteria:
Recent receipt of experimental HIV-1 vaccines
Recent use of immunomodulatory agents
Hypersensitivity or serious reactions to study vaccine components
Active opportunistic infections
Facility Information:
Facility Name
AIDS Research Alliance
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
We'll reach out to this number within 24 hrs