AMP stands for Antibody Mediated Prevention. This is the idea of giving people antibodies to see if they will protect people from getting infected with HIV.
The AMP study is a new idea for HIV prevention that is related to what has been done in HIV vaccine research. In traditional HIV vaccine studies, people get a vaccine and researchers wait to see if their bodies will make antibodies against HIV in response. In this study, we will skip that step, and give people the antibodies directly. We will do this with an intravenous infusion, commonly known as an “IV” or “getting a drip”. This is the first study testing whether antibodies can prevent HIV infections in people.
Antibodies are natural proteins in the body that fight disease. They are able to attach to the outside of bacteria and viruses to block them from causing an infection. This is called “neutralizing.” You can think of antibodies as the body’s soldiers, working to protect people from infections. This antibody, named VRC01, is a broadly neutralizing antibody to HIV. Lab tests have shown that broadly neutralizing antibodies like VRC01 can prevent infection by many different strains of HIV from around the world. It does this by attaching to the places on the virus that it uses to attach to healthy cells, blocking an infection. The AMP Study will help us learn if the VRC01 antibody will prevent HIV infection in people.
The IV or drip starts out with a bag of normal saline solution, the same kind of salt water that can be given to people who are dehydrated. The VRC01 antibody gets added to the saline solution by a pharmacist. The amount of antibody that gets added is based on the study participant’s weight, so people who weigh more will get more of the antibody. Two doses of antibody will be tested to see if they might work to prevent HIV infections: a dose of 10 mg/kg, and a dose of 30 mg/kg. Some people will get a placebo, which is just the normal saline solution with no antibody added to it. The IV or drip is given to the study participant for 30-60 minutes. To get an IV, a sterile needle is used to place a small plastic tube into a vein in the participant’s arm. A bag of fluid is hung from a pole and connected to a pump, which controls how quickly the contents of the bag flow through the tube into the participant’s arm.
The study is being conducted by two organizations, the HIV Vaccine Trials Network and the HIV Prevention Trials Network. Both organizations and all of the participating study clinics work in collaboration with community stakeholders to ensure that this research is acceptable to the local community and respectful of local cultures.