A Phase I/II, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of anti-HIV vaccine, in HIV-1-Infected Subjects Currently Under Treatment with Highly Active Antiretroviral Therapy (HAART)

The purpose of the research is to see if anti-HIV vaccine is safe and tolerable in subjects infected with HIV. A similar vaccine was tested in monkeys infected with a virus like HIV.  Monkeys that received the anti-HIV vaccine vaccine along with anti-HIV drugs had lower viral loads (amounts of HIV virus in the blood) than the monkeys treated with vaccine alone or with anti-HIV drugs alone. Untreated monkeys infected with the HIV-related virus experienced an increase in their viral loads. All treated animals, including the ones that received only vaccine, survived longer than the untreated animals. The study will also look at the immune responses (how your body fights off infections) in your body after you receive the vaccinations.

The vaccine used in the study is an anti-HIV vaccine that is given as a patch on the skin. The vaccine has not been approved by the Food and Drug Administration (FDA) for use in treating HIV infection in humans. The safety of the vaccine is currently being studied in subjects with HIV in another study in Europe. In the future, any new safety information from the European study will be shared with subjects participating in this study. If this study and the European study show that the vaccine is safe, additional studies will be done to see if the vaccine can decrease viral loads in HIV-infected persons.

This vaccine is not expected to destroy all HIV viral cells in your body.  It is not expected to create a cure for HIV.  It is being researched to provide people infected with HIV an additional treatment for their disease. 

• Men and women age 18-50 years
• HIV-1 infection
• Nadir CD4+ cell count greater than 250 cells/mm³  at any time prior to the study entry
• Screening HIV-1 RNA 50copies/mL or less at least twice within 30 days prior to study entry