The study is expected to begin enrolling participants in 2016. It will be done in these locations in Africa:
Another AMP study very similar to this one is being done in the US and South America. It will also begin enrolling participants in 2016. The other AMP study is called HVTN 704/HPTN 085.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, is paying for this study. NIAID, the HIV Vaccine Trials Network (HVTN), and the HIV Prevention Trials Network (HPTN) developed this study. The Dale and Betty Bumpers Vaccine Research Center (VRC), which is part of NIAID, is providing the VRC01 antibody for the study.
The HVTN and HPTN are both international collaborations of scientists, educators, and community members searching for effective ways to prevent HIV. The HVTN focuses on safe and effective HIV vaccines, while the HPTN focuses on other HIV prevention methods such as pre-exposure prophylaxis and treatment as prevention. The HVTN is funded by NIAID. The HPTN is co-funded by NIAID, the National Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH).
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:
The HVTN 703/HPTN 081 AMP Study tests an experimental antibody against HIV in women in sub-Saharan Africa. 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 getting HIV infected.
Antibodies are one of the natural ways that our bodies fight infection. Giving people antibodies to prevent an infection is an accepted medical practice that is more than 100 years old. For example, doctors give people natural antibodies to prevent infections like hepatitis A and B and chicken pox. Some of the antibodies that are used for preventing infections are made in laboratories. Manufactured antibodies have been used successfully to prevent a dangerous respiratory infection in infants called RSV.
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.
Laboratory tests have shown that the VRC01 antibody can prevent many different strains of HIV from infecting cells. VRC01 also prevented animals from getting infected. The AMP study will help us learn if the VRC01 antibody will prevent HIV infection in people.
The VRC01 antibody was discovered in the blood of a person who had HIV and whose body was able to control the infection without antiretroviral drugs for many years before needing treatment.
The VRC01 antibody is not made from live HIV, killed HIV, or HIV-infected human cells. It cannot cause HIV infection or AIDS. The antibody is made using the same kinds of processes used to make other medicines.
VRC01 will be given using intravenous infusions. This is more commonly known as getting an IV, or getting a drip. The IV infusion is given to the study participant for 30-60 minutes. To get an IV infusion, 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 infusion. One third will get a lower dose of the antibody in their IV infusion. One third will get an infusion of sterile salt water without any antibody in it. This is called a placebo.
The study will enroll and follow about 1500 women at study sites in Africa.
Women in sub-Saharan Africa are among those 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.
To join this study, a woman must be healthy, between 18 and 40 years old, and not infected with HIV. She cannot be pregnant or breastfeeding. There are also other criteria that must be met. We will ask about their medical history, give them a physical exam, and take blood and urine samples for testing. We will also ask about their recent sexual activity and drug use.
We do not know all the risks of VRC01 because it has only been given to about 140 people in earlier studies. Although no one in those studies had any serious health problems related to the antibody, there is always the possibility of problems no one expects.
That is why one purpose of this study is to test whether the antibody is safe when given to more people. Each participant’s health will be watched closely throughout the study.
We don’t know. The AMP studies are the first ones designed to find out if the VRC01 antibody prevents HIV infection. Participants should not expect to be protected from HIV by participating in the AMP study. In fact, one third of participants will get a placebo.
All participants in this study will be counseled about ways to reduce their risk for HIV infection.
When discussing methods of reducing HIV risk, participants and counselors will talk about things such as condom use, PrEP, staying sober and drug-free during sexual activities, reducing the numbers of partners, and discussing HIV status with potential partners. Counselors can also provide participants with information about PrEP access in their area.
The study is randomized. This means that whether a participant gets a higher dose of the antibody, a lower dose of the antibody, or the placebo is completely random, like flipping a coin. Randomization is done so that people in the 3 groups are similar. Participants in all the groups will get the same type of individualized counseling to reduce their HIV risk, so HIV risk should be similar across the groups. We know that even with risk reduction efforts some people will still get HIV infected. The key difference between study groups is whether people get the VRC01 antibody or the placebo. Because everything else about the groups is similar, any difference in HIV infections between groups is likely due to the antibody.
The study is expected to take around 5 years overall. Each participant will be in the study for a little less than 2 years.
There are no current plans to give the antibody to participants after the study or to seek licensure for public use. Instead, we will use what is learned in this study to:
No, we do not expect people to have positive results on common HIV tests. Samples of human blood with VRC01 have been tested using several common HIV test kits to see if getting VRC01 can cause a positive HIV test result. In these laboratory experiments, this did not happen. More experiments are being done to confirm this result.
Protecting the health and respecting the rights of participants are top priorities for everyone in the HVTN and HPTN. Without volunteers, we would never be able to find new methods for preventing HIV infection.
A first step in protecting the rights of study participants is to give them information about the study before they join. This process is called informed consent. Clinic staff will give people information about the antibody and the study procedures, the possible risks and benefits to participants, and the rights that they have. These include the right to receive any new information about the study that could affect whether they want to stay in it, and the right to leave the study at any time.
During the study, the clinic staff will monitor participants to make sure the antibody is not causing any health problems. The clinic staff will also ask participants about any social problems they may experience from being in the study. If a participant has a health or social problem related to being in the study, clinic staff will help them.
There are also several groups involved in protecting participants’ rights and well-being: