This is a next step in HIV research
Learn about a research study evaluating if investigational medications can aid your own body to control HIV viral load without ART
DISCLAIMER: The drugs included in this study are investigational and are not yet proven to be safe or effective. Unknown side effects can occur and can be serious. Stopping your antiretroviral treatment also has some risks. The M19-965 Study has been designed to minimize potential risks as much as possible, but please make sure you discuss with the study doctor the risks of participating in the study as well as other questions or concerns you have.
The M19-965 Study is evaluating 2 investigational medications for HIV to see if they may safely and effectively control HIV viral load by aiding the body’s natural immune response to the HIV virus.
About the Study
The M19-965 Study is a global HIV research study with approximately 90 study sites worldwide. We are looking to enroll around 140 people living with HIV around the world. Once in the study, you will be required to stop taking your ART, at the direction of the study doctor, in order to receive the investigational medication. Stopping ART may have risks; therefore, all participants will be closely monitored by an experienced HIV study team. The study doctor may restart you on your ART if your viral loads increase, if your CD4 decreases, or if you have symptoms or events that can put you or your partner at significant risk. You will continue to participate in the study even if you have restarted ART.
Study Medications
The M19-965 Study is studying 2 investigational medications, budigalimab and ABBV-382. These medications work differently than antiretroviral therapy and were developed to see if they may aid the immune system to fight the virus. This is not a cure for HIV. The goal of this research study is to see if one or both are safe and effective in controlling HIV without ART. As those medications are investigational, we do not know yet if they are safe. Your study team will give you more information about the risks of taking those investigational medications.
The investigational medications will be delivered by infusion, a needle into a vein, during the first 8 weeks of the study. Participants will be randomly selected to receive either both investigational medications, 1 investigational medication and 1 placebo, or 2 placebos. Neither the participants nor the study team will know which is being given. Explore each video to learn more about the investigational medication.
About Study Visits
This study includes two types of visits: infusion and non-infusion. Infusion visits are conducted in person at the study sites where you will receive infusions of the investigational medications or the placebo. Non-infusion visits may potentially be split between in person and over the phone, and no investigational medication will be given. You will have regular blood tests, amongst other tests and procedures, to monitor viral loads, CD4 levels, and overall health and symptoms. Watch the videos below to learn more about the types of visits.
Important Study Tests and Procedures
This M19-965 Study includes a process called an ATI, analytical treatment interruption, where you will be required to stop taking your antiretroviral therapy (ART). In order to qualify for this study, you must be on a stable ART and willing to stop it during participation when directed by the study doctor. ART will be restarted if your viral loads increase, if your CD4 decreases, or if you have symptoms or events that can put you or your partner at significant risk. This study is also “placebo-controlled” so there will be participants that receive a placebo rather than the investigational medication. Neither you nor the study team will know which is being given. Learn more about study tests and procedures in the video below.
About Participating
How do I qualify?
You may be eligible to participate if you:
- Are 18 to 70 years of age
- Have been diagnosed with HIV
- Have been on ART for at least 12 months
- Have been on your current ART for at least 8 weeks
- Agree to stop your ART only at the direction of the study doctor
- Agree to take measures to prevent HIV transmission during the study
Benefits and risks of participating
If you qualify and decide to participate:
- Your health will be closely monitored by an experienced HIV study team for risks related to the investigational study drugs and related to stopping your ART (called ATI). The study team will give you more information about what those risks are
- You will receive all study medications and related care at no cost
- Your participation could help advance medical knowledge about the treatment of HIV and improve patient care
You may also be reimbursed for your time and effort in participating.
Your safety while participating is our highest priority. If you have questions or concerns at any point throughout the study, a study staff member is available. Your privacy will be maintained throughout the study. Your participation is voluntary, and you are free to withdraw at any time.
About Participating
Importance of HIV Research
New therapies for HIV are constantly evolving—a therapy that could enable people living with HIV to reach and maintain undetectable virus levels could allow people to live without ART. All new treatments are subject to rigorous evaluations and reviews through clinical research studies that are conducted by qualified medical professionals. It is only after being proven safe and effective that these medications can be approved for use.
Volunteers in research studies play a vital role in the evaluation of investigational medications. It is thanks to volunteer participation that we can hope to advance HIV treatments that may allow people to live with undetectable levels of the virus without the burden of lifelong treatment.
We do not yet know if the investigational medications in the M19-965 Study will work, are safe, or if they have side effects. Your participation will potentially help us learn more and bring us a step closer to expanding therapy options for people living with HIV worldwide.
Talk to Your Doctor
Frequently Asked Questions
A research study, also known as a clinical trial, is a scientific study that evaluates the way an investigational medication works in the body, including assessing its safety, effectiveness, or the way it is processed in the body. A research study may show that the investigational medication is better than, as good as, or worse than the standard treatment or a placebo. Qualified doctors, nurses, and other medical professionals are responsible for conducting research studies. Learn more about how research studies work in the video below.
View Study Sites Information
DISCLAIMER: The drugs included in this study are investigational and are not yet proven to be safe or effective. Unknown side effects can occur and can be serious. Stopping your antiretroviral treatment also has some risks. The M19-965 Study has been designed to minimize potential risks as much as possible, but please make sure you discuss with the study doctor the risks of participating in the study as well as other questions or concerns you have.
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