The TWO TO FOUR Study for HIV prevention in healthy adults.

What are clinical studies?

Clinical studies are research studies that help doctors and scientists learn more about a disease or condition and find new ways to treat, diagnose, or prevent it. They are also called clinical trials. To learn more about clinical studies, click the button below.

About clinical studies

What is the TWO TO FOUR Study?

This study is being done in healthy adults to learn how switching from cabotegravir long-acting (given every two months) to cabotegravir ultra long-acting (given every four months) affects drug levels in the body. Both cabotegravir long-acting and cabotegravir ultra long-acting are investigational study drugs.

Who can participate?

You may be able to participate in this study if you meet the following criteria:

18 years of age and older
Healthy as determined by medical evaluation

Additional criteria for participation will also apply.

African American father and son talking outside, Frequently asked questions, TWO TO FOUR Study, HIV prevention, adults

What happens during the study?

You will first need to give your consent, or permission, to join the study by reading and signing the Informed Consent Form. The study has 4 periods: Screening, Pre-Switch Study Treatment, Post-Switch Study Treatment, and an optional Long-Term Follow-up. The total duration of study involvement for participants who complete the study and the optional Long-Term Follow-up Period will be about 32 months.

Screening

The study team will collect information about your health and run tests to see if you qualify.

Pre-Switch Study Treatment

You will have at least 11 clinic visits. Some will involve receiving the investigational study drug, cabotegravir long-acting, while others will focus on health checks and tests.

Post-Switch Study Treatment

You will have at least 19 clinic visits and 3 phone call visits that could involve health checks, tests, and receiving the investigational study drug, cabotegravir ultra long-acting.

Long-Term Follow-up

(optional)

No study treatment will be given during this period, but information on safety and how your body deals with the investigational study drug will be collected. Visit schedules will depend on your last dose of the investigational study drug, cabotegravir ultra long-acting, and how long you have been in the study.

When do I receive study treatment?

During the Pre-Switch Study Treatment Period, all participants will receive the investigational study drug, cabotegravir long-acting, by injection. During the Post-Switch Study Treatment Period, all participants will receive the investigational study drug, cabotegravir ultra long-acting, by injection.