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)

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)

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.

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