Evaluating the safety and effectiveness of a new HIV vaccine.

Treatment Category:  Treatment Experienced

Study Description
A5369 is a study that will evaluate the safety and effectiveness of a new vaccine in HIV- infected persons. This vaccine, which is called a therapeutic or treatment vaccine, is not meant to prevent HIV infection but rather to improve how the immune system responds to HIV infection.

Why is this study being done?

  • The study will look at whether an anti-HIV vaccine is safe and effective in people infected with HIV.
  • The study will look at whether or not the anti-HIV vaccine improves immune responses.

Who can join?

  • HIV-1-infected individuals between the ages of 18 and 65 years
  • Current CD4 cell count greater than 500, and never less than 350
  • On HIV treatment for at least 2 years with undetectable HIV viral loads for at least 3 years
  • No active Hepatitis B or C, no diabetes

What do I need to do in the study?
Participants will be randomly assigned (assigned by chance) to one of these groups:

Arm 1: p24CE1/2 pDNA vaccine (at weeks 0 and 4) followed by p24CE1/2 + full-length p55gag pDNA vaccine (at weeks 12 and 24)
Arm 2: Full-length p55gag pDNA vaccine (at weeks 0, 4, 12, and 24)
Arm 3: Placebo (at weeks 0, 4, 12, and 24)

The vaccines/placebo will be administered by intramuscular injection/electroporation.

Participants must be taking and planning to continue their current anti-HIV medications.
All participants will be followed in the study for up to 48 weeks.

What treatments or drugs are involved with this study?
The vaccines will be provided throughout the study. HIV medications will not be supplied through this study.