What is a clinical study?
Clinical studies are research studies that help doctors and scientists learn more about a disease or medical condition and new ways to treat, diagnose, or prevent it. They are also called clinical trials. To learn more about clinical studies, click the button below.
What is the EMBRACE Study?
This study is being done to learn more about the study drug, VH3810109, in combination with cabotegravir (CAB), a medicine already approved as a combination regimen with rilpivirine for HIV treatment. Researchers want to compare the effects and safety of the study drug with those of the current standard treatment for HIV.
Who can participate?
You may qualify for this study if you meet the following criteria. Additional participation criteria also apply.
Age
18 to 70 years of age
Treatment
Taking standard treatment for HIV continuously for at least 6 months
Diagnosis
Diagnosed with HIV-1
Treatment response
Successful response to current HIV treatment (less virus inside your body as a result of current treatment)
Screening Period
Up to 2.5 months; 1 visit
To see if you qualify for the study, the study team will ask questions about your health and the medicines you take and will run some tests.
Study Treatment Period
24 months; 28 visits
You will be assigned by chance to receive either the study drug, VH3810109, in combination with CAB, or to continue taking standard treatment. Your chances of receiving the study drug are 4 times greater than your chances of receiving standard treatment.
The study drug is given as either an intravenous (IV) infusion (Group 1) or a subcutaneous (SC) infusion (Group 2) on Day 1 and then every 4 months for the remainder of the treatment period.
- An IV infusion means the medicine is given slowly into a vein in your arm.
- An SC infusion means the medicine is given slowly through a needle into the fatty layer just beneath the skin of your abdomen.
CAB is given as an injection (shot) into a muscle in your buttocks on Day 1 and once a month after that.
Study Treatment Groups
If you are assigned to Group 3, you’ll continue taking standard treatment as prescribed by your doctor.
Group 1
VH3810109 IV infusion + CAB
Group 2
VH3810109 SC infusion + CAB
Group 3
Standard treatment
Follow-Up After Discontinuation Period (Groups 1 and 2 only)
12 months; 4 visits
If you are in Group 1 or 2, you’ll have a visit for tests every 3 months for 1 year after your final dose of the study treatment.
What tests and health checks can I expect?
Some of the tests you will have during the study include:
Height / Weight
Vital signs
Physical exam
Heart health
Blood tests
Urine / pregnancy test
Mental health check
Questionnaires
You will not have all of these tests at every visit. Talk to the study doctor to learn more.
Talk to your doctor if you’re interested in learning more about the EMBRACE Study. If you are already participating in the study, visit the Resource Center page for additional information.
Participation in the study is voluntary and you can choose to leave at any time.