Trial Information

Summary: Therapeutic Vaccine for HIV+ Individuals

This is a randomized, double-blinded, Phase I, dose-escalation study designed to evaluate the safety, tolerability and immunogenicity of a therapeutic vaccine, EP HIV 1090, when administered as a weekly therapeutic immunization to HIV-1 infected volunteers who are on stable antiretroviral regimen. Volunteers will be randomized to receive one of two different doses of the vaccine, or a placebo. The duration of the study is 24 weeks (the treatment period is 5 weeks with 5 months of follow-up), with a series of five injections delivered via Biojector, a needle-free injection device.

Patient Inclusion Criteria

• HIV 1-positive males or females at least 18 years of age
• Documented T-cell count above 350 cells/mm3 for the past six months
• Documented undetectable viral load (less or equal 50 copies/ml) for the past six months

Patient Exclusion Criteria

• No active Hepatitis B or C

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Trial listings updated: June 1, 2008 at 6:32:50 AM