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)

Status unconfirmed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00532974

Run by

Epimmune

People needed

32

Starts

2006-10-01

Expected to finish

2008-04-01

Last updated by the study team

2007-12-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• AIDS Research Alliance — West Hollywood, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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