A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection among men and transgender persons who have sex with men.
What is HVTN 704/HPTN 085?
The AMP Study (also known as HVTN 704/HPTN 085) tests an experimental antibody against HIV. AMP stands for Antibody Mediated Prevention. This is the idea of giving people antibodies that fight HIV to see if they will protect people from becoming HIV infected.
The AMP study tests an antibody called VRC01, a manufactured antibody against HIV. This 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 to the vaccine. In this study, we will skip that step, and give people the antibodies directly.
Who is participating in the study?
The study will enroll and follow about 2,700 men and transgender people who have sex with men in North America, South America, and Switzerland. To join this study, a person must be healthy, between 18 and 50 years old, and not infected with HIV. They cannot be pregnant or breastfeeding. There are also other criteria that must be met. We will ask people about their medical history, give them a physical exam, and take blood and urine samples for testing. We will also ask people about their recent sexual activity and drug use.
Why is HVTN 704/HPTN 085 important?
Men and transgender people who have sex with men are among at highest risk of HIV infection. They have the greatest need for new tools to prevent HIV infection, and it is important to include them in studies looking at new prevention methods.
All HVTN and HPTN studies work toward our shared mission of finding effective ways to prevent HIV infection. The main purposes of the study are to:
* Gather more information about the safety of VRC01;
* See if people can receive the antibody without becoming too uncomfortable;
* Test whether the VRC01 antibody can prevent HIV infection in people;
* Find out how much VRC01 is needed for protection, if we find that it does work to prevent HIV infection.
What happens during the study?
VRC01 will be given using intravenous infusions. This is more commonly known as getting an IV, or getting a drip. The IV is given to the study participant every eight weeks 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.
There will be 3 different groups in this study. One third of study participants will get a higher dose of the antibody in their IV. One third will get a lower dose of the antibody in their IV. One third will get an infusion of sterile salt water without any antibody in it. This is called a placebo. Participants will be enrolled in the study for about two years.
➤ For study-specific materials, please log into the member portal on the HVTN website.
HIV Prevention & The AMP Study
Bnabs (Broadly Neutralizing Antibodies)
HIV and the Prevention Landscape
The Importance of Prevention Research: The AMP Study
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HVTN 704/HPTN 085 Version 3.0
- Protocol V3.0 – 15 June 2017
- Protocol V3.0, Full Protocol Amendment #2 – 15 June 2017
- Protocol V3.0, LoA #1 – 29 August 2017
- Protocol V3.0, Clarification Memo #1 – 9 November 2017
- Protocol V3.0, LoA #2 – 7 March 2018
HVTN 704/HPTN 085 Version 2.0
- Protocol V2.0 - 19, July 2016
- Protocol V2.0, LoA #1 - 14 December 2016
- Protocol V2.0, Full Protocol Amendment #1 – 19 July 2016
HVTN 704/HPTN 085 Version 1.0