General Study Questions

How long will I be in the study?

You will be in the study for up to 38 months (about 3 years, not including the Continued Access Phase).

How many times will I have to go to the study site?

You will visit the study site up to 33 times for tests and health checks.

What are the benefits of participating in the study?

There is a chance that the study treatment will help keep your HIV viral load down and your symptoms suppressed. Your health will be monitored continuously throughout the study. Even if you do not directly benefit from participating in the study, any information collected may help researchers learn more about VH3810109 and about treating other adults living with HIV in the future.

Will it cost me anything to be in the study?

You will receive the study treatment (study drug or standard treatment) and all study tests at no cost to you.

Who is sponsoring the study?

The global biopharma company GlaxoSmithKline and the global pharma company that specializes in HIV treatment, Viiv Healthcare, are sponsoring the study. They pay the study doctor and study site to run this study.

What if I decide to join the study and then change my mind?

Participation in the study is voluntary. If you decide to join and then change your mind, you can leave the study at any time. Leaving the study will not affect your regular medical care.

Study Treatment Questions

Which study treatment will I receive?

You will be assigned by chance to receive either the study drug, VH3810109, in combination with cabotegravir (CAB), or to continue taking standard treatment for HIV as prescribed by your doctor. Your chances of receiving the study drug are 4 times greater than your chances of receiving standard treatment.

How is the study drug given?

The study drug, VH3810109, is given as either an intravenous (IV) infusion or a subcutaneous (SC) infusion every 4 months, depending on the group to which you are assigned. 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 once a month.

Are there any side effects from the study drug?

As with all medicines, there is the possibility of side effects, which are unwanted and unintended effects of a medicine. Talk to the study doctor for more information on possible side effects. Your health will be closely monitored throughout the entire study. Tell the study doctor if you notice any side effects or changes in your health.