ACTG A5369 – HIV p24CE Vaccine Study

STUDY BASICS

Are you HIV-positive and currently taking anti-HIV medications? If so, you may be eligible to participate in a research study to help find out if HIV vaccines can safely and effectively strengthen the body’s immune system and improve the body’s ability to fight HIV. Compensation is provided.

STUDY PURPOSE

HIV (human immunodeficiency virus) is a virus that attacks the immune system. Without a strong immune system, the body has trouble fighting off infections and diseases. Medications can help people with HIV stay healthy, but there is currently no cure. The purpose of this research study is to help find out if two different investigational HIV vaccines can safely and effectively strengthen the body’s immune system and improve the body’s ability to fight HIV. Researchers hope their findings will lead to better ways to control HIV infection in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• HIV-positive
• On stable HIV treatment for a minimum of 2 years
• Have an undetectable HIV viral load
• Do not have a cardiac pacemaker, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulator
• No current hepatitis B or C infection
• No history of seizures
• No excessive tattoos on the shoulder or thigh muscle
• Not diagnosed with diabetes
• Not pregnant or breastfeeding

WHAT PARTICIPANTS CAN EXPECT

Participation in the study will involve up to 10 study visits and 4 phone calls over 12 months. Participants will be randomly assigned (like the flip of a coin) to be placed into one of three groups. Two groups will receive an HIV vaccine and one group will receive a placebo that does not contain any vaccine or medicine. Participants will receive four injections throughout the course of the study. This study will also look at whether the intramuscular (IM, or into the muscle) injection of the study vaccines given along with electroporation will be well tolerated. Electroporation, or EP, uses electrical stimulation to help the body better absorb the vaccine. Other study procedures include providing medical history, physical exam, EKG, and blood and urine tests.