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)

Epimmune

Status and phase: Unknown; Phase 1

Conditions: HIV Infections

Treatments: Biological: EP1090

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00532974

EP-HIV-1090

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind