The CUATRO Study for adults and adolescents living with HIV

What is a clinical study?

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, watch the video below.

Understanding Clinical Trials

What is the CUATRO Study?

The CUATRO Study is designed to evaluate the effectiveness and safety of a new ultra long-acting HIV study drug compared to the currently approved version. The new ultra long-acting study drug will require less intramuscular injections per year than the approved long-acting drug.

Four individuals of different ages, genders, and ethnicities embracing one another while smiling at the camera

Who can participate?

You may be able to participate in this study if you meet the following criteria. Additional criteria for participation will also apply.

Age

12 years of age or older

Treatment

Have been taking current oral antiretroviral therapy (ART) for HIV continuously for at least 6 months

Medical status

Diagnosed with HIV-1

Treatment response

Had a successful and sustained response to current HIV treatment (less of the virus inside your body because of current treatment) for the past 12 months

What happens during the study?

To learn more about the Informed Consent process watch this video

If you choose to continue on the ultra long-acting study drug during the Extension Phase, you may remain on the study drug until it is approved in your country, which could be about 3 more years.

Screening Phase
Up to 28 days
1 visit

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

Initiation Phase
3 months
4 visits

You will receive long-acting HIV drug.

Maintenance Phase
20 months
13 visits

You will be assigned by chance (like flipping a coin) to receive either the ultra long-acting study drug or the approved long-acting drug.

Extension Phase
12 months
3-5 visits

You will be given the option to continue with the ultra long-acting study drug, even if you were receiving the approved long-acting HIV drug in the Maintenance Phase.

Long-Term Follow-up Phase*
Up to 12 months

There will be 1 to 3 more visits to check on your health.

*For people who still have side effects that need to be checked, people whose study treatment did not work as expected, people who received one or more injections of the ultra long-acting study drug and then stopped treatment, or people who become pregnant during the study. Participants who become pregnant are followed monthly so they will have more visits.

How does the study drug work?

Both the study drug and the approved HIV drug contain 2 separate HIV medicines to help keep the amount of HIV in the blood low. The 2 medicines release slowly over time to keep around the same level of medicine in your body between injections. The new study drug is called ultra long-acting because it releases more slowly than the approved long-acting version, which means you can receive doses less often.